Anesthesiology
Review Panel
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- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- NDHNail, Fixation, Bone, Metallic2Product Code
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- HRZProsthesis, Knee, Hinged (Metal-Metal)3Product Code
- HSAProsthesis, Knee, Hemi-, Femoral3Product Code
- HSBRod, Fixation, Intramedullary And Accessories2Product Code
- NDIStaple, Fixation, Bone, Metallic2Product Code
- HRSPlate, Fixation, Bone2Product Code
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented2Product Code
- HSHProsthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)2Product Code
- HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer2Product Code
- HTGProsthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented2Product Code
- HTNWasher, Bolt Nut2Product Code
- HTYPin, Fixation, Smooth2Product Code
- HWCScrew, Fixation, Bone2Product Code
- HXAProsthesis, Tendon, Passive2Product Code
- JDBProsthesis, Elbow, Semi-Constrained, Cemented2Product Code
- JDCProsthesis, Elbow, Constrained, Cemented2Product Code
- JDDProsthesis, Upper Femoral2Product Code
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal2Product Code
- JDHProsthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal3Product Code
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2Product Code
- JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)3Product Code
- JDNImplant, Fixation Device, Spinal2Product Code
- JDODevice, Fixation, Proximal Femoral, Implant2Product Code
- JDPCondylar Plate Fixation Implant2Product Code
- JDQCerclage, Fixation2Product Code
- JDRStaple, Fixation, Bone2Product Code
- JDSNail, Fixation, Bone2Product Code
- JDTCap, Bone1Product Code
- JDWPin, Fixation, Threaded2Product Code
- JECComponent, Traction, Invasive2Product Code
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- JWIProsthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained2Product Code
- JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained2Product Code
- KIGProsthesis, Wrist, Constrained, Polymer2Product Code
- KMBProsthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented2Product Code
- KMCProsthesis, Hip, Semi-Constrained, Composite/Metal2Product Code
- KMDProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite2Product Code
- KRNMetal Cemented Constrained Femorotibial Knee Prosthesis3Product Code
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2Product Code
- KRPProsthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal3Product Code
- KRQProsthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer2Product Code
- KRSProsthesis, Knee, Hemi-, Femoral (Uncemented)3Product Code
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component2Product Code
- KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component2Product Code
- KTXProsthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented2Product Code
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)3Product Code
- KWBProsthesis, Hip, Hemi-, Acetabular, Cemented, Metal3Product Code
- KWDProsthesis, Toe, Hemi-, Phalangeal2Product Code
- KWEProsthesis, Finger, Constrained, Metal, Uncemented3Product Code
- KWFProsthesis, Finger, Polymer2Product Code
- KWGProsthesis, Finger, Constrained, Metal/Polymer3Product Code
- KWHProsthesis, Toe, Constrained, Polymer2Product Code
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer2Product Code
- KWJProsthesis, Elbow, Hemi-, Humeral, Metal3Product Code
- KWKAppliance, Nail/Blade/Plate Combination, Single Component2Product Code
- KWLProsthesis, Hip, Hemi-, Femoral, Metal2Product Code
- KWMProsthesis, Wrist, Semi-Constrained2Product Code
- KWNProsthesis, Wrist, Carpal Lunate2Product Code
- KWOProsthesis, Wrist, Carpal Scaphoid2Product Code
- KWPAppliance, Fixation, Spinal Interlaminal2Product Code
- KWQAppliance, Fixation, Spinal Intervertebral Body2Product Code
- KWRProsthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented3Product Code
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented2Product Code
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2Product Code
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented2Product Code
- KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2Product Code
- KXAProsthesis, Hip, Femoral, Resurfacing2Product Code
- KXBProsthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer3Product Code
- KXCProsthesis, Ankle, Cemented, Non-Constrained3Product Code
- KXDProsthesis, Hip, Constrained, Metal3Product Code
- KXEProsthesis, Wrist, Hemi-, Ulnar2Product Code
- KYIProsthesis, Wrist, Carpal Trapezium2Product Code
- KYJProsthesis, Finger, Constrained, Polymer2Product Code
- KYKProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite2Product Code
- KYMMetallic Cemented Glenoid Hemi-Shoulder Prosthesis3Product Code
- KYNProsthesis, Wrist, Constrained, Metal3Product Code
- LBCProsthesis, Finger, Constrained, Metal, Cemented3Product Code
- LGEProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing2Product Code
- LODBone Cement2Product Code
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented2Product Code
- LRNWire, Surgical2Product Code
- LTOSpacer, Cement3Product Code
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented2Product Code
- LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite2Product Code
- LYPAccessories, Fixation, Spinal Interlaminal2Product Code
- LYTFixation Accessory2Product Code
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2Product Code
- LZYProsthesis, Hip, Hemi-, Femoral, Metal Ball2Product Code
- MAIFastener, Fixation, Biodegradable, Soft Tissue2Product Code
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar2Product Code
- MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish2Product Code
- MBBBone Cement, Antibiotic2Product Code
- MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented2Product Code
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer2Product Code
- MBIFastener, Fixation, Nondegradable, Soft Tissue2Product Code
- MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous2Product Code
- MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)2Product Code
- MBVProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer2Product Code
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate2Product Code
- MJWProsthesis, Subtalar, Plug, Polymer2Product Code
- MNHOrthosis, Spondylolisthesis Spinal Fixation2Product Code
- MNIOrthosis, Spinal Pedicle Fixation2Product Code
- MNUStaple, Absorbable2Product Code
- MQPSpinal Vertebral Body Replacement Device2Product Code
- MQVFiller, Bone Void, Calcium Compound2Product Code
- MRYAppliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component2Product Code
- NDDCerclage, Fixation, Metallic2Product Code
- NDERod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible2Product Code
- NDFPlate, Fixation, Bone, Non-Spinal, Metallic2Product Code
- NDGWasher, Bolt, Nut, Non-Spinal, Metallic2Product Code
- NDJScrew, Fixation, Bone, Non-Spinal, Metallic2Product Code
- NDKSystem, External Fixator (With Metallic Invasive Components)2Product Code
- NDLPin, Fixation, Smooth, Metallic2Product Code
- NDMPin, Fixation, Threaded, Metallic2Product Code
- NDNCement, Bone, Vertebroplasty2Product Code
- NJAAccessory, System, External Fixator, Containing Antimicrobial Agent2Product Code
- NJDProsthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer2Product Code
- NKBThoracolumbosacral Pedicle Screw System2Product Code
- K250092HC Biologics Osteopoint Spinal Fixation System2Cleared 510(K)
- K242900VADER® Pedicle System and VADER®one Pedicle System2Cleared 510(K)
- K243916Primus Spinal Fixation System2Cleared 510(K)
- K243908Tiger 2 System2Cleared 510(K)
- K243249TriALTIS™ Spine System2Cleared 510(K)
- K243946EffortMed Spinal Fixation System2Cleared 510(K)
- K243259MASADA Modular Spinal Fixation System2Cleared 510(K)
- K243693NEO Pedicle Screw System™2Cleared 510(K)
- K242297Reform Pedicle Screw System2Cleared 510(K)
- K243281LOCK-IN Spinal Fixation System2Cleared 510(K)
- K2316554CIS® Chiron Spinal Fixation System2Cleared 510(K)
- K242764MediRod Pedicle Screw System2Cleared 510(K)
- K243004Xpine Spinal Fixation System2Cleared 510(K)
- K243106CarboClear® Hybrid Pedicle Screw System2Cleared 510(K)
- K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod System2Cleared 510(K)
- K243007CD Horizon™ Spinal System2Cleared 510(K)
- K242899NOVA Minimally Invasive System2Cleared 510(K)
- K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System2Cleared 510(K)
- K241657MSFX MIKRON SPINAL FIXATION SYSTEM2Cleared 510(K)
- K242042TriALTIS™ Spine System2Cleared 510(K)
- K240233Pitkar Spinal Pedicle Screw System2Cleared 510(K)
- K242069Eminent Spine Scoliosis Deformity Pedicle Screw System2Cleared 510(K)
- K240180Orthopeasia Spinal Fixation System2Cleared 510(K)
- K241892Cortera™ Spinal Fixation System2Cleared 510(K)
- K233793CarboClear® X Pedicle Screw System2Cleared 510(K)
- K241494Pantheon Pedicle Screw and Iliac Bolt Fixation System2Cleared 510(K)
- K241863Erisma® Lp Spinal Fixation System; Erisma® LP MIS2Cleared 510(K)
- K241519Invictus® Small Stature Spinal Fixation System2Cleared 510(K)
- K240963Spinal System2Cleared 510(K)
- K241258Ingenix Spinal System2Cleared 510(K)
- K241276Vector™ Pedicle Screw System2Cleared 510(K)
- K240685Salvo® Spine System2Cleared 510(K)
- K240392JAZZ Spinal System2Cleared 510(K)
- K240526POWEReam Xia/Serrato2Cleared 510(K)
- K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System2Cleared 510(K)
- K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement2Cleared 510(K)
- K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System2Cleared 510(K)
- K240737G Surgical Marksman MIS System2Cleared 510(K)
- K240350AnyPlus II Spinal Fixation System2Cleared 510(K)
- K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)2Cleared 510(K)
- K240539Vital™ Spinal Fixation System2Cleared 510(K)
- K2326074CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM2Cleared 510(K)
- K232628VADER® Pedicle System2Cleared 510(K)
- K234048M.U.S.T. Pedicle Screw System - Extension2Cleared 510(K)
- K233960INNOVERSE Spinal System2Cleared 510(K)
- K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments2Cleared 510(K)
- K233300POWEReam 1/4 Drive2Cleared 510(K)
- K233684TriALTIS™ Spine System2Cleared 510(K)
- K233455ARx MIS Spinal Screw System2Cleared 510(K)
- K232719ProMIS Extension Rod System2Cleared 510(K)
- K231443Mini-OSTEO Pedicle Fixation System2Cleared 510(K)
- K231694MASADA Modular Spinal Fixation System2Cleared 510(K)
- K233234PressON Spinal Fixation System2Cleared 510(K)
- K231737ANAX™ 5.5 Spinal System2Cleared 510(K)
- K231069PERLA® TL Posterior Thoraco-lumbar Fixation System2Cleared 510(K)
- K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System2Cleared 510(K)
- K232561Ripley Spinal Screw System by SAGICO2Cleared 510(K)
- K231744VyLink™ Spinal Screw System2Cleared 510(K)
- K230116Vital™ Spinal Fixation System2Cleared 510(K)
- K232341CarboClear® Pedicle Screw System2Cleared 510(K)
- K231658VEOS Spinal Fixation System2Cleared 510(K)
- K230961Zeus Spinal System2Cleared 510(K)
- K232650KHEIRON® Spinal Fixation System, including patient specific K-ROD2Cleared 510(K)
- K232275Invictus® Spinal Fixation System2Cleared 510(K)
- K231479TriALTIS Spine System2Cleared 510(K)
- K230974NIDO™ Pedicle Screw System2Cleared 510(K)
- K232218Zenius™ Spinal System2Cleared 510(K)
- K231811Zavation Connector System2Cleared 510(K)
- K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)2Cleared 510(K)
- K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System2Cleared 510(K)
- K231098LineSider® Spinal System2Cleared 510(K)
- K231931Adena-Zina Spinal System2Cleared 510(K)
- K231799INERTIA® CONNEXX™ Modular Pedicle Screw System2Cleared 510(K)
- K231844ProMIS™ Fixation System2Cleared 510(K)
- K223806VERTICALE® Triangular Fixation System2Cleared 510(K)
- K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement2Cleared 510(K)
- K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.2Cleared 510(K)
- K230762EDEN Spinal Fixation MIS System2Cleared 510(K)
- K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi2Cleared 510(K)
- K223096Dark Star Deformity Pedicle Screw System2Cleared 510(K)
- K222229Advanced LumFix Spinal Fixation System2Cleared 510(K)
- K223529PressON Spinal Fixation System2Cleared 510(K)
- K212220ArtFX Spinal Fixation System2Cleared 510(K)
- K230766Altus Spine Monaco Pedicle Screw System2Cleared 510(K)
- K230482Swedge™ Pedicle Screw Fixation System2Cleared 510(K)
- K222105RESPONSE 5.5/6.0 Cannulated Screw System2Cleared 510(K)
- K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System2Cleared 510(K)
- K230063G Surgical Marksman Spinal Deformity System2Cleared 510(K)
- K223494CD Horizon Spinal System2Cleared 510(K)
- K223181NuVasive Reline System2Cleared 510(K)
- K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.2Cleared 510(K)
- K223273ASTRA Spine System2Cleared 510(K)
- K222614Zavation Spinal System2Cleared 510(K)
- K222516Mercury® II Spinal System2Cleared 510(K)
- K223274Momentum® MIS Posterior Spinal Fixation System2Cleared 510(K)
- K212700Dyflex-II2Cleared 510(K)
- K222031Spinal Inner Fixation System2Cleared 510(K)
- K222415Rexious Spinal Fixation System2Cleared 510(K)
- K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods2Cleared 510(K)
- K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLH™ POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM2Cleared 510(K)
- K220297True Tulip, True M.I.S.2Cleared 510(K)
- K211027Altus Spine Pedicle Screw System2Cleared 510(K)
- K222110Mariner RDX System2Cleared 510(K)
- K221745Sterile Posterior Spinal Fixation System2Cleared 510(K)
- K222362Salvo® Spine System2Cleared 510(K)
- K221403Cortera Spinal Fixation System2Cleared 510(K)
- K221776NextGen Pedicle Screw System2Cleared 510(K)
- K221905INERTIA CONNEXX Modular Pedicle Screw System2Cleared 510(K)
- K221332OsteoCentric Spine MIS Pedicle Fastener System2Cleared 510(K)
- K220486Kentrospine PSS Pedicle Screw System2Cleared 510(K)
- K201788EDEN Spinal Fixation System2Cleared 510(K)
- K211981KHEIRON® Spinal Fixation System2Cleared 510(K)
- K2032334CIS Chiron Spinal Fixation System2Cleared 510(K)
- K221244CD Horizon™ Spinal System2Cleared 510(K)
- K220285PINE Pedicle Screw System2Cleared 510(K)
- K220341ARx Modular Spinal System2Cleared 510(K)
- K220724CD Horizon™ Spinal System and PASS LP™ Spinal System2Cleared 510(K)
- K214006Invictus® Spinal Fixation System2Cleared 510(K)
- K220025ARx® Spinal System2Cleared 510(K)
- K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)2Cleared 510(K)
- K213750VyLink™ Spinal Screw System2Cleared 510(K)
- K212627True Tulip, True M.I.S.2Cleared 510(K)
- K213470PERLA® TL Posterior Osteosynthesis System2Cleared 510(K)
- K213281PASS LP™ Spinal System, CD Horizon™ Spinal System2Cleared 510(K)
- K213460Invictus Spinal Fixation System2Cleared 510(K)
- K212692Mariner Pedicle Screw System2Cleared 510(K)
- K203607MOSS VRS Spinal System2Cleared 510(K)
- K212185Golden Isles Pedicle Screw System2Cleared 510(K)
- K212066Adena-Zina System2Cleared 510(K)
- K211414KHEIRON Spinal Fixation System2Cleared 510(K)
- K211958CD Horizon Spinal System2Cleared 510(K)
- K210963ENNOVATE Spinal System2Cleared 510(K)
- K203023Pisces Spinal System2Cleared 510(K)
- K211113Zavation Spinal System2Cleared 510(K)
- K211606Mariner Deformity System2Cleared 510(K)
- K201737Posterior Spinal Fixation System2Cleared 510(K)
- K211323ASTRA Spine System2Cleared 510(K)
- K210306GII Spinal Fixation System2Cleared 510(K)
- K210816True Tulip, True M.I.S.2Cleared 510(K)
- K210874Reliance Spinal Screw System2Cleared 510(K)
- K210637CD Horizon™ Spinal System2Cleared 510(K)
- K210549ARx Spinal System2Cleared 510(K)
- K210427M.U.S.T. Midline Cortical (MC) Screw System2Cleared 510(K)
- K210420Goblin and Goblin LS Pedicle Screw Systems2Cleared 510(K)
- K210539CoreLink Midline Fixation System2Cleared 510(K)
- K210716CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments2Cleared 510(K)
- K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw System2Cleared 510(K)
- K210275Polaris Spinal System2Cleared 510(K)
- K201420Republic Spine Dark Star Spinal System2Cleared 510(K)
- K2024984CIS SARA Spine System, 4CIS VERTU Spine System2Cleared 510(K)
- K203507Vitality® Spinal Fixation System2Cleared 510(K)
- K203482M.U.S.T. Pedicle Screw Extension and Long Tab Implants2Cleared 510(K)
- K200922Altus Spine HA Pedicle Screw System2Cleared 510(K)
- K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPS2Cleared 510(K)
- K203506PERLA® TL posterior osteosynthesis system2Cleared 510(K)
- K202505GetSet Surgical GoPLF! Posterior Lateral Fusion System2Cleared 510(K)
- K203452Nano FortiFix® System2Cleared 510(K)
- K203222PERLA TL Posterior Osteosynthesis System2Cleared 510(K)
- K203163ARx Illiac Spinal Screw System2Cleared 510(K)
- K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System2Cleared 510(K)
- K203367LineSider™ Spinal System2Cleared 510(K)
- K203317CarboClear X Pedicle Screw System2Cleared 510(K)
- K203056Invictus™ Spinal Fixation System2Cleared 510(K)
- K201568Calvary Spine Pedicle Screw System2Cleared 510(K)
- K202476Salvo® Spine System2Cleared 510(K)
- K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System2Cleared 510(K)
- K202528Cannulated Power Driver Attachment2Cleared 510(K)
- K200937ACURA Stabilization System2Cleared 510(K)
- K202894Wiltrom Spinal Fixation System2Cleared 510(K)
- K201427Trivergent Spinal Fixation System2Cleared 510(K)
- K200794AccelFix Spinal Fixation System2Cleared 510(K)
- K202771CD Horizon Spinal System2Cleared 510(K)
- K202327Invictus™ OsseoScrew® System2Cleared 510(K)
- K201659KHEIRON® Spinal Fixation System2Cleared 510(K)
- K201407CD Horizon™ Spinal System2Cleared 510(K)
- K202328CD Horizon Spinal System2Cleared 510(K)
- K190600ORION Spinal System2Cleared 510(K)
- K200981Mega Plus MIS Spine System2Cleared 510(K)
- K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System2Cleared 510(K)
- K201648Sterispine™ PS2Cleared 510(K)
- K201780True Tulip System, True M.I.S. System2Cleared 510(K)
- K201751Pedicle Screw System2Cleared 510(K)
- K190408Spinal Fixation System2Cleared 510(K)
- K200322Altus Spine Pedicle Screw System2Cleared 510(K)
- K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.02Cleared 510(K)
- K200303Reform Pedicle Screw System2Cleared 510(K)
- K192930Dymaxeon Spine System2Cleared 510(K)
- K200519CarboClear® II Pedicle Screw System2Cleared 510(K)
- K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System2Cleared 510(K)
- K200666Stryker Xia 3 Power Adaptor2Cleared 510(K)
- K200070ARx Spinal System2Cleared 510(K)
- K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System2Cleared 510(K)
- K193211Nano FortiFix® System2Cleared 510(K)
- K200267LOSPA® IS™ Spinal Fixation System2Cleared 510(K)
- K191655MEGAFIX® Pedicle Screw Spinal System2Cleared 510(K)
- K200381Daytona® Small Stature Spinal System2Cleared 510(K)
- K193472OrthoCircle Spine Pedicle Screw System2Cleared 510(K)
- K193396PERLA® TL posterior osteosynthesis system2Cleared 510(K)
- K193270CapLOX II®/TowerLOX® MIS Pedicle Screw System2Cleared 510(K)
- K193365M.U.S.T. Pedicle Screw System2Cleared 510(K)
- K190981NEX-D2 Posterior Fixation System2Cleared 510(K)
- K192800Streamline TL Spinal Fixation System2Cleared 510(K)
- K193465CorticaLINK Spinal Fusion Platform2Cleared 510(K)
- K193011CD Horizon™ Fenestrated Screw Set2Cleared 510(K)
- K192680Percusys® Plus Pedicle Screw System2Cleared 510(K)
- K193219G Surgical Marksman System2Cleared 510(K)
- K192938Invictus™ Spinal Fixation System2Cleared 510(K)
- K192396Streamline MIS Spinal Fixation System2Cleared 510(K)
- K192915GMA 2.0 Pedicle Screw System2Cleared 510(K)
- K192121Black Diamond Pedicle Screw System2Cleared 510(K)
- K192268Europa Pedicle Screw System2Cleared 510(K)
- K190636NuVasive® Reline® 4.5-5.0 System2Cleared 510(K)
- K191932Momentum™ Posterior Spinal Fixation System2Cleared 510(K)
- K191576Mercury® Spinal System, Overwatch® Spinal System2Cleared 510(K)
- K191726mont blanc & mont blanc MIS Spinal Systems2Cleared 510(K)
- K191810Curiteva Pedicle Screw System2Cleared 510(K)
- K191494Facilis™ Spinal System2Cleared 510(K)
- K191575ARx Spinal System2Cleared 510(K)
- K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments2Cleared 510(K)
- K183091Elaris Pedicle Screw System2Cleared 510(K)
- K1904714CIS® Chiron Spinal Fixation System2Cleared 510(K)
- K191757EUROPA Pedicle Screw System2Cleared 510(K)
- K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation System2Cleared 510(K)
- K191045Salvo™ Spine System2Cleared 510(K)
- K190360LineSider™ Spinal System2Cleared 510(K)
- K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.02Cleared 510(K)
- K190762The JASPER Spinal Fixation System II2Cleared 510(K)
- K182416NOVA Minimally Invasive System2Cleared 510(K)
- K182544AccelFix Spinal Fixation System2Cleared 510(K)
- K183639Mariner Outrigger Revision System2Cleared 510(K)
- K190567KeYi Spinal Fixation System2Cleared 510(K)
- K190376PASS LP Spinal System2Cleared 510(K)
- K190317Zavation Spinal System2Cleared 510(K)
- K183550Vitality® Spinal Fixation System2Cleared 510(K)
- K182375CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®2Cleared 510(K)
- K190361Zavation Spinal System2Cleared 510(K)
- K180337EUROPA Pedicle Screw System2Cleared 510(K)
- K183430Modular Spinal Fixation System2Cleared 510(K)
- K182771ISS-JAZZ Screw System and JAZZ CAP SP2Cleared 510(K)
- K182974NuVasive Reline System2Cleared 510(K)
- K180626Pedimax II - Pedicular Screw Spinal System2Cleared 510(K)
- K182970EUROPA™ Pedicle Screw System2Cleared 510(K)
- K182478Whistler Modular Pedicle Screw System2Cleared 510(K)
- K181824CBT Screw Fixation System2Cleared 510(K)
- K182954Salvo™ Spine System2Cleared 510(K)
- K182339LEUCADIA AUTOLOK™ Pedicle Screw System2Cleared 510(K)
- K183168OpenLoc-L Spinal Fixation System2Cleared 510(K)
- K183080Mega Plus Spine System2Cleared 510(K)
- K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw System2Cleared 510(K)
- K183117PathLoc-L MIS Spinal System2Cleared 510(K)
- K182598VersaLink™ Fixation System2Cleared 510(K)
- K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System2Cleared 510(K)
- K182283FUSE Pedicle Screw System2Cleared 510(K)
- K182239OLYMPIC Posterior Spinal Fixation System2Cleared 510(K)
- K182240PASS LP Spinal System2Cleared 510(K)
- K172826Cellent Spinal Systems2Cleared 510(K)
- K182059Prase MIS Spinal System2Cleared 510(K)
- K182377CarboClear® Pedicle Screw System2Cleared 510(K)
- K181980OsseoScrew System2Cleared 510(K)
- K181995Chiral Surgical Pedicle Screw System2Cleared 510(K)
- K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System2Cleared 510(K)
- K181821MOSS VRS Spinal System2Cleared 510(K)
- K182119CD HORIZON™ Spinal System2Cleared 510(K)
- K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw2Cleared 510(K)
- K181978Zenius™, Iliad™ and Kora™ Spinal Fixation Systems2Cleared 510(K)
- K181584Redi-Spine2Cleared 510(K)
- K181677Kodiak Spinal Fixation System2Cleared 510(K)
- K181554Stowe Pedicle Screw System2Cleared 510(K)
- K181495Republic Spine Dark Star Spinal System2Cleared 510(K)
- K180226TREND II Spinal Fixation System- STEP Series2Cleared 510(K)
- K181339Altus Spine Pedicle Screw System2Cleared 510(K)
- K173645JASPER Spinal Fixation System2Cleared 510(K)
- K173487CarboClear® Pedicle Screw System2Cleared 510(K)
- K180655Viking Lumbar Polyaxial Screw System2Cleared 510(K)
- K181139OLYMPIC Posterior Spinal Fixation System2Cleared 510(K)
- K181119Range (Denali and Mesa) Spinal Systems2Cleared 510(K)
- K181281Altus Spine Pedicle Screw System2Cleared 510(K)
- K181188EVEREST Spinal System2Cleared 510(K)
- K180220SAGICO OSI Spinal System by Osimplant2Cleared 510(K)
- K180686SeaSpine Daytona Small Stature Spinal System2Cleared 510(K)
- K180433ENNOVATE®2Cleared 510(K)
- K180458FOCUS Pedicle Screw System2Cleared 510(K)
- K180301AXIS 5.5 Lumbar Pedicle Screw System2Cleared 510(K)
- K172967Mercury® Spinal System2Cleared 510(K)
- K180324Patriot Spinal Fixation System2Cleared 510(K)
- K180376K2M Patient Specific Rods2Cleared 510(K)
- K180210CREO® Stabilization System2Cleared 510(K)
- K180475CapLOX II® / TowerLOX® MIS Pedicle Screw System2Cleared 510(K)
- K180153X-spine Cortical Bone Screw System2Cleared 510(K)
- K173180Mega Plus Spine System2Cleared 510(K)
- K173249CD HORIZON™ Spinal System2Cleared 510(K)
- K172267IRENE Thoracolumbar Fixation System2Cleared 510(K)
- K180176SeaSpine NewPort Spinal System2Cleared 510(K)
- K173185SEURAT™ Universal Pedicle Screw System2Cleared 510(K)
- K173882SeaSpine Mariner Pedicle Screw System2Cleared 510(K)
- K173814DeGen Medical E3 MIS Pedicle Screw System2Cleared 510(K)
- K172548Wiltrom Spinal Fixation System2Cleared 510(K)
- K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® System2Cleared 510(K)
- K173508Everest Spinal System2Cleared 510(K)
- K173130Reform® Midline Cortical Screw System2Cleared 510(K)
- K173524ANAX 5.5™ Spinal System2Cleared 510(K)
- K173484CorticaLINK Spinal Fusion Platform2Cleared 510(K)
- K173131Rexious Spinal Fixation System2Cleared 510(K)
- K173126Arisstos™ Spinal System2Cleared 510(K)
- K173522Solanas® Posterior Stabilization System2Cleared 510(K)
- K172469TiLock Modular Spinal System2Cleared 510(K)
- K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations2Cleared 510(K)
- K172808CosmoLock Pedicle Screw System2Cleared 510(K)
- K172546AnyPlus® Spinal Fixation System2Cleared 510(K)
- K172724XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory2Cleared 510(K)
- K171894NuVasive® Precept™ Spinal System2Cleared 510(K)
- K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument System2Cleared 510(K)
- K172101ROMEO® 2 Posterior Osteosynthesis System2Cleared 510(K)
- K171832Range/Denali/Mesa Spinal System2Cleared 510(K)
- K171582NEO Pedicle Screw System™2Cleared 510(K)
- K171570Additional VIPER PRIME™ screws with fenestrations2Cleared 510(K)
- K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System2Cleared 510(K)
- K171526Zenius™, lliad™ and Kora™ Spinal Fixation Systems2Cleared 510(K)
- K172175CapSure® PS System2Cleared 510(K)
- K161225Paonan Armstrong Posterior Spinal Fixation System2Cleared 510(K)
- K170861Premier2Cleared 510(K)
- K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems2Cleared 510(K)
- K171758M.U.S.T. Combined Set Screws2Cleared 510(K)
- K171559True Spinal Fixation System2Cleared 510(K)
- K171838TiLock2 Spinal System2Cleared 510(K)
- K171907Vitality® Spinal Fixation System2Cleared 510(K)
- K170710True Spinal Fixation System2Cleared 510(K)
- K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System2Cleared 510(K)
- K163011PHA S1 Spinal System2Cleared 510(K)
- K170045Swedge™ Pedicle Screw Fixation System2Cleared 510(K)
- K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw System2Cleared 510(K)
- K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System2Cleared 510(K)
- K171438Palisade™ Pedicular Fixation System2Cleared 510(K)
- K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws2Cleared 510(K)
- K170611SETx Pedicle Screw System2Cleared 510(K)
- K170989Dymaxeon Spine System2Cleared 510(K)
- K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory2Cleared 510(K)
- K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems2Cleared 510(K)
- K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System2Cleared 510(K)
- K170543VIPER PRIME™ Screws with Fenestrations2Cleared 510(K)
- K170108Xultan 5.5 Pedicle Screw System2Cleared 510(K)
- K170964Zenius Spinal System2Cleared 510(K)
- K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems2Cleared 510(K)
- K170251Threshold™ Pedicular Fixation System2Cleared 510(K)
- K170268Fortress™ Pedicular Fixation System2Cleared 510(K)
- K170266Palisade™ Pedicular Fixation System2Cleared 510(K)
- K170255Threshold™ V2 Pedicular Fixation System2Cleared 510(K)
- K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation System2Cleared 510(K)
- K170347CD HORIZON™ Fenestrated Screw Set2Cleared 510(K)
- K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System2Cleared 510(K)
- K162995Ibis® Pedicle Screw System2Cleared 510(K)
- K170654USS System2Cleared 510(K)
- K170528Sterispine™ PS2Cleared 510(K)
- K170126NuVasive® Reline® 4.5-5.0 System2Cleared 510(K)
- K163604SeaSpine® Daytona® Small Stature Spinal System2Cleared 510(K)
- K163056Revolution™ Spinal Fixation System2Cleared 510(K)
- K170163Erisma® LP Spinal Fixation System2Cleared 510(K)
- K163566Hubble I System2Cleared 510(K)
- K170061ProMIS™ Fixation System2Cleared 510(K)
- K162786PASS LP Spinal System2Cleared 510(K)
- K161231Facilis™ Spinal System2Cleared 510(K)
- K162764JAZZ FRAME SYSTEM2Cleared 510(K)
- K163301CD HORIZON® Spinal System2Cleared 510(K)
- K162134ENNOVATE Spinal System2Cleared 510(K)
- K162912VIPER PRIME™ additions to the VIPER® System2Cleared 510(K)
- K162160Preference Elite Pedicle Screw System2Cleared 510(K)
- K162232MOSS 100 Pedicle Screw System2Cleared 510(K)
- K162379CD HORIZON® Spinal System2Cleared 510(K)
- K162576FORTEZZA Spinal Stabilization System2Cleared 510(K)
- K162750Libra Pedicle Screw System2Cleared 510(K)
- K162367Erisma® LP MIS2Cleared 510(K)
- K162061M.U.S.T. Pedicle Screw System2Cleared 510(K)
- K161842Overwatch Spine System2Cleared 510(K)
- K162494CD HORIZON® Spinal System2Cleared 510(K)
- K161014NuVasive® Reline® System2Cleared 510(K)
- K160640PASS XS Spinal System2Cleared 510(K)
- K161535SeaSpine® NewPort™ Spinal System2Cleared 510(K)
- K161516G Surgical Marksman MIS System2Cleared 510(K)
- K161766PathLoc-L MIS Spinal System2Cleared 510(K)
- K161914Genesys Spine TiLock Cortical Spinal System2Cleared 510(K)
- K161387Mont Blanc and Mont Blanc MIS Spinal Systems2Cleared 510(K)
- K161627PASS LP Spinal System2Cleared 510(K)
- K161499VertiForm Posterior Fixation System2Cleared 510(K)
- K161369EVEREST Spinal System2Cleared 510(K)
- K161694Threshold™ Pedicular Fixation System2Cleared 510(K)
- K152920Savannah-T® Pedicle Screw System2Cleared 510(K)
- K160722CorticaLINK Spinal Fusion Platform2Cleared 510(K)
- K160904Expedium Spine System, VIPER and VIPER 2 Systems2Cleared 510(K)
- K160926F1 MPS Modular Pedicle Screw System2Cleared 510(K)
- K160820PressON Pro Spinal Fixation System2Cleared 510(K)
- K161363Arsenal Spinal Fixation System2Cleared 510(K)
- K160989NuVasive® Reline® System2Cleared 510(K)
- K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems2Cleared 510(K)
- K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation System2Cleared 510(K)
- K160902Mariner Pedicle Screw System2Cleared 510(K)
- K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector2Cleared 510(K)
- K160986Xenco Medical Pedicle Screw System2Cleared 510(K)
- K153152Syzygy Stabilization System2Cleared 510(K)
- K153453Inertia Pedicle Screw and Deformity Correxxion System2Cleared 510(K)
- K160216Revolution Spinal Fixation System2Cleared 510(K)
- K153413PASS LP Spinal System2Cleared 510(K)
- K151704Diplomat® Spinal System2Cleared 510(K)
- K151977icotec Pedicle System2Cleared 510(K)
- K160466Response 5.5 Spine System2Cleared 510(K)
- K153326Erisma-LP Spinal Fixation System2Cleared 510(K)
- K153323Palisade Pedicular Fixation System2Cleared 510(K)
- K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems2Cleared 510(K)
- K152781Adena-Zina System2Cleared 510(K)
- K153589CD HORIZON Spinal System2Cleared 510(K)
- K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System2Cleared 510(K)
- K153525Seneka II Polyscrew Pedicle Fixation System2Cleared 510(K)
- K153664M.U.S.T. Pedicle Screw System2Cleared 510(K)
- K153463CD HORIZON Spinal System, IPC POWEREASE System2Cleared 510(K)
- K152968Arsenal Spinal Fixation System2Cleared 510(K)
- K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory2Cleared 510(K)
- K151770Libra Pedicle Screw System2Cleared 510(K)
- K153031RANGE/DENALI/MESA Spinal System2Cleared 510(K)
- K151974Polaris Spinal System2Cleared 510(K)
- K152248CD HORIZON Spinal System2Cleared 510(K)
- K152039Genesys Spine TiLock2 Spinal System2Cleared 510(K)
- K152457CD HORIZON Spinal System2Cleared 510(K)
- K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System2Cleared 510(K)
- K151921STERISPINE PS2Cleared 510(K)
- K151747STERISPINE PS2Cleared 510(K)
- K151849Seneka I Polyscrew Pedicle Fixation System2Cleared 510(K)
- K151727Everest Spinal System2Cleared 510(K)
- K151733Xenco Medical Pedicle Screw System2Cleared 510(K)
- K152148Fortress Pedicular Fixation System2Cleared 510(K)
- K150896Vitality Spinal Fixation System2Cleared 510(K)
- K151422Reform Pedicle Screw System2Cleared 510(K)
- K151216Everest Spinal System2Cleared 510(K)
- K150380ProMIS Fixation System2Cleared 510(K)
- K151196Nautilus Spinal System2Cleared 510(K)
- K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System2Cleared 510(K)
- K150856Reform Pedicle Screw System2Cleared 510(K)
- K143110GALAXY MIS Screw System2Cleared 510(K)
- K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System2Cleared 510(K)
- K150184Dymaxeon Spine System2Cleared 510(K)
- K142835Iliad Pedicle Screw System and Zenius Pedicle Screw System2Cleared 510(K)
- K151215Mercury Spinal System2Cleared 510(K)
- K150600Response 5.5/6.0 Spine System2Cleared 510(K)
- K143683APEX-DL Spine System2Cleared 510(K)
- K150417ASTRA SPINE SYSTEM2Cleared 510(K)
- K150185Mont Blanc Spinal System2Cleared 510(K)
- K143684NuVasive Reline System2Cleared 510(K)
- K143363VENUS Spinal Fixation System2Cleared 510(K)
- K143731IMPLANET Spine System (ISS)2Cleared 510(K)
- K143019CD HORIZON Spinal System, IPC POWEREASE System2Cleared 510(K)
- K150507Santis Pedicle Screw System2Cleared 510(K)
- K150325Range/Denali/Mesa Spinal System2Cleared 510(K)
- K142531F1-Modular Pedicle Screw System2Cleared 510(K)
- K150390Nautilus Spinal System2Cleared 510(K)
- K142576Spinal System2Cleared 510(K)
- K143230Palladian Lumbar Pedicle Screw System2Cleared 510(K)
- K143375CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments2Cleared 510(K)
- K143569CD HORIZON Spinal System2Cleared 510(K)
- K141222NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM2Cleared 510(K)
- K150178CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K150092STERISPINE PS Pedicle Screw2Cleared 510(K)
- K143200MIS Z-Pedicle Screw System2Cleared 510(K)
- K143633CREO Stabilization System2Cleared 510(K)
- K142360Everest Spinal System2Cleared 510(K)
- K142939Revolution Spinal Fixation System2Cleared 510(K)
- K143334Range/Denali/Mesa Spinal System2Cleared 510(K)
- K141398PASS LP SPINAL SYSTEM2Cleared 510(K)
- K143149Arsenal Spinal Fixation System2Cleared 510(K)
- K141186FIREBIRD SPINAL FIXATION SYSTEM2Cleared 510(K)
- K141695ACROSSPINE PEDICLE SCREW SYSTEM2Cleared 510(K)
- K143248Reform Pedicle Screw System2Cleared 510(K)
- K143403Threshold Pedicular Fixation System2Cleared 510(K)
- K142737MAS PLIF Fixation system2Cleared 510(K)
- K142146IBIS PEDICLE SCREW SYSTEM2Cleared 510(K)
- K141282PGS 5.5 MM CANNULATED PEDICLE SCREW2Cleared 510(K)
- K143141CD HORIZON Spinal System2Cleared 510(K)
- K142591CD HORIZON Spinal System2Cleared 510(K)
- K142499Reline System2Cleared 510(K)
- K142185EXPEDIUM VERSE SPINE SYSTEM2Cleared 510(K)
- K142847CD HORIZON Spinal System2Cleared 510(K)
- K141850FLOSPINE PEDICLE SCREW SYSTEM2Cleared 510(K)
- K142381Xia 3 Spinal System2Cleared 510(K)
- K141604CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K141804POLARIS SPINAL SYSTEM - HA COATED2Cleared 510(K)
- K141873RANGE/MESA/DENALI SPINAL SYSTEM2Cleared 510(K)
- K141291VERTIFORM POSTERIOR FIXATION SYSTEM2Cleared 510(K)
- K141372MERCURY SPINAL SYSTEM2Cleared 510(K)
- K141988M.U.S.T PEDICLE SCREW SYSTEM2Cleared 510(K)
- K141044M.U.S.T. EXTENSION2Cleared 510(K)
- K132049THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS2Cleared 510(K)
- K141494CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K133402K2M MODULAR HOOKS2Cleared 510(K)
- K141605CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K140765RANGE/MESA/DENALI SPINAL SYSTEM2Cleared 510(K)
- K140802STERISPINE PS2Cleared 510(K)
- K141147RANGE SPINAL SYSTEM2Cleared 510(K)
- K140529EVEREST SPINAL SYSTEM2Cleared 510(K)
- K140238EXCELLA III-D SPINAL DEFORMITY SYSTEM2Cleared 510(K)
- K140123POLARIS SPINAL SYSTEM -TRANSLATION SCREW2Cleared 510(K)
- K140010FORTRESS PEDICLE SCREW SYSTEM2Cleared 510(K)
- K140219PICASSO II MIS SPINAL SYSTEM2Cleared 510(K)
- K140696STREAMLINE TL SPINAL FIXATION SYSTEM2Cleared 510(K)
- K133366ORTHROS POSTERIOR STABILIZATION SYSTEM2Cleared 510(K)
- K133743BAXANO SURGICAL MIS SPINAL SYSTEM2Cleared 510(K)
- K140449CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K140457NAUTILUS SPINAL SYSTEM2Cleared 510(K)
- K133944RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM2Cleared 510(K)
- K133221ARSENAL SPINAL FIXATION SYSTEM2Cleared 510(K)
- K133746POLARIS SPINAL SYSTEM2Cleared 510(K)
- K133350REVERE STABILIZATION SYSTEM2Cleared 510(K)
- K133564MODIFICATION TO NAUTILUS SPINAL SYSTEM2Cleared 510(K)
- K132925SAVANNAH-T, REDUCTION, SAVANNAH-T, HIGH-TOP, SAVANNAH-T, MONOAXIAL MID-TOP, SAVANNAH-T, LOW-TOP, SAVANNAH-LINK2Cleared 510(K)
- K133369TIGER SPINE SYSTEM2Cleared 510(K)
- K133063SANTIS PEDICLE SCREW SYSTEM2Cleared 510(K)
- K133066SPINESELECT POLYSCREW PEDICLE SCREW SYSTEM2Cleared 510(K)
- K132878M.U.S.T. EXTENSION2Cleared 510(K)
- K133291ST360 DEGREES SPINAL FIXATION SYSTEM2Cleared 510(K)
- K133188MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL2Cleared 510(K)
- K132328CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K133086TITLE 2 POLYAXIAL SPINAL SYSTEM2Cleared 510(K)
- K132884PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM2Cleared 510(K)
- K132639CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K132603APEX SPINE SYSTEM2Cleared 510(K)
- K132014GSB GLOBAL SPINAL BALANCE SYSTEM2Cleared 510(K)
- K132866NAUTILUS SPINAL SYSTEM2Cleared 510(K)
- K132471CD HORIZON SPINAL SYSTEM2Cleared 510(K)
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- K131878LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM2Cleared 510(K)
- K131785PAGODA PEDICLE SCREW SYSTEM2Cleared 510(K)
- K130932FIREBIRD SPINAL FIXATION SYSTEM2Cleared 510(K)
- K132111CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K131100STREAMLINE TL SPINAL SYSTEM2Cleared 510(K)
- K130877EXPEDIUM SPINE SYSTEM2Cleared 510(K)
- K131119SOLANAS POSTERIOR STABILIZATION SYSTEM2Cleared 510(K)
- K130632STERISPINE PS PEDICLE SCREW2Cleared 510(K)
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- K130291S4 SPINAL SYSTEM2Cleared 510(K)
- K130646CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K130286STREAMLINE MIS SPINAL FIXATION SYSTEM2Cleared 510(K)
- K130176FIREBIRD SPINAL FIXATION SYSTEM2Cleared 510(K)
- K123939S4 SPINAL SYSTEM2Cleared 510(K)
- K123373NAUTILUS SPINAL SYSTEM2Cleared 510(K)
- K123717UCENTUM2Cleared 510(K)
- K123549POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM2Cleared 510(K)
- K123809CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K123623ILLICO MIS POSTERIOR FIXATION SYSTEM2Cleared 510(K)
- K123134EASYSPINE SYSTEM2Cleared 510(K)
- K121670MEDYSSEY CANNULATED PEDICLE SCREW2Cleared 510(K)
- K123352S4 SPINAL SYSTEM2Cleared 510(K)
- K122571MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM2Cleared 510(K)
- K122845ES2 SPINAL SYSTEM MODEL 48280XXXX2Cleared 510(K)
- K123451POLARIS SPINAL SYSTEM - BALLISTA II RODS2Cleared 510(K)
- K122901FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM2Cleared 510(K)
- K122229VICEROY SPINAL SYSTEM2Cleared 510(K)
- K123246CD HORIZON SPIRE Z SPINAL SYSTEM2Cleared 510(K)
- K121786DYMAXEON SPINE SYSTEM2Cleared 510(K)
- K121728TIGER SPINE SYSTEM2Cleared 510(K)
- K122862CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K122226REVERE STABILIZATION SYSTEM2Cleared 510(K)
- K120891TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM2Cleared 510(K)
- K122433CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K121568DALI SPINAL FIXATION SYSTEM2Cleared 510(K)
- K122352NUVASIVE PRECEPT SPINAL SYSTEM2Cleared 510(K)
- K121316LANX SPINAL FIZATION SYSTEM2Cleared 510(K)
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- K121619NUVASIVE POLYAXIAL SPINAL SCREWS2Cleared 510(K)
- K121103LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S2Cleared 510(K)
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- K120469ERISMA-LP2Cleared 510(K)
- K120714PICASSO MIS SPINAL FIXATION SYSTEM2Cleared 510(K)
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- K121940LANX SPINAL FIXATION SYSTEM2Cleared 510(K)
- K120838SYNTHES MATRIX SYSTEM2Cleared 510(K)
- K121299STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD2Cleared 510(K)
- K120467SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM2Cleared 510(K)
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- K120564CALYPSO SYSTEM2Cleared 510(K)
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- K121342XIA 4.5 SPINAL SYSTEM2Cleared 510(K)
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- K112607SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ...2Cleared 510(K)
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- K120928SYNTHES MATRIX SYSTEM2Cleared 510(K)
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- K111358SYNTHES USS2Cleared 510(K)
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- K111449REVOLVE ADDITIONAL IMPLANTS2Cleared 510(K)
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- K110070TSRH SPINAL SYSTEM2Cleared 510(K)
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- K103072REVERE SACRAL PLATES2Cleared 510(K)
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- K103040LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)2Cleared 510(K)
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- K102514NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM2Cleared 510(K)
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- K101070EXPEDIUM SPINE SYSTEM2Cleared 510(K)
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- K100970STAINLESS STEEL SPINAL SYSTEM2Cleared 510(K)
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- K100438POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM2Cleared 510(K)
- K100409POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM2Cleared 510(K)
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- K093668SYNTHES MATRIX MIS RODS2Cleared 510(K)
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- K093434VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM2Cleared 510(K)
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- K093058TSRH SPINAL SYSTEM2Cleared 510(K)
- K092287NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM2Cleared 510(K)
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- K092626MODIFICATION TO: EXPEDIUM SPINE SYSTEM2Cleared 510(K)
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- K092610MODIFICATION TO BEACON STABILIZATION SYSTEM2Cleared 510(K)
- K091974MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
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- K091782REVERE 6.35 STABILIZATION SYSTEM2Cleared 510(K)
- K092073MONOPOLY PEDICLE SCREW SYSTEM2Cleared 510(K)
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- K091219DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM2Cleared 510(K)
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- K090657MODIFICATION TO: S4 SPINAL SYSTEM2Cleared 510(K)
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- K090408MODIFICATION TO: DSS STABILIZATION SYSTEM2Cleared 510(K)
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- K082942MODFICATION TO: EXPEDIUM SPINE SYSTEM2Cleared 510(K)
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- K081684BLACKSTONE PEDICLE SCREW SYSTEM2Cleared 510(K)
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- K073245EXTENDED VERTIFLEX SPINAL SCREW SYSTEM2Cleared 510(K)
- K073510ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM2Cleared 510(K)
- K073267ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM2Cleared 510(K)
- K073430VALEO PEDICLE SCREW SPINAL SYSTEM2Cleared 510(K)
- K073480LIFE SPINE CROSS CONNECTOR2Cleared 510(K)
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- K072022VALEO PEDICLE SCREW SPINAL SYSTEM2Cleared 510(K)
- K071921INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS)2Cleared 510(K)
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- K070282ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM2Cleared 510(K)
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- K063772EXPEDIUM SPINE SYSTEM2Cleared 510(K)
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- K062270RADIUS SPINAL SYSTEM2Cleared 510(K)
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- K061563EBI ARRAY SPINAL SYSTEM2Cleared 510(K)
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- K060748MODIFICATION TO XIA 4.5 SPINAL SYSTEM2Cleared 510(K)
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- K060203MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
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- K051275LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM2Cleared 510(K)
- K052151SYNTHES PANGEA MONOAXIAL SYSTEM2Cleared 510(K)
- K052747MODIFICATION TO:CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K052609MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
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- K050439CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K043488MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K050282MODIFICATION TO TSRH SPINAL SYSTEM2Cleared 510(K)
- K043321MODIFICATION TO: CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K043232UCR SPINAL SYSTEM2Cleared 510(K)
- K042962MODIFICATION TO CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K042772EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATION DEVICE2Cleared 510(K)
- K042702SILHOUETTE SPINAL FIXATION SYSTEM2Cleared 510(K)
- K042953MODIFICATION TO PROTEX STABILIZATION SYSTEM2Cleared 510(K)
- K042886CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K042790CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K042167MODIFICATION TO: CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K041801EXPEDIUM MIS SPINE SYSTEM2Cleared 510(K)
- K041167PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM2Cleared 510(K)
- K033901MERLIN SPINE SYSTEM2Cleared 510(K)
- K032560ARROWHEAD SPINAL SYSTEM2Cleared 510(K)
- K033312EBI TOP LOADING MAS SPINAL FIXATION SYSTEM2Cleared 510(K)
- K032033CD HORIZON SPINAL SYSTEM2Cleared 510(K)
- K030369OPUS SPINAL SYSTEM2Cleared 510(K)
- K031424EBI SPINELINK SPINAL FIXATION SYSTEM2Cleared 510(K)
- K031355EBI SPINELINK - II SPINAL FIXATION SYSTEM2Cleared 510(K)
- K030087SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM2Cleared 510(K)
- K030625SPINAL CONCEPTS INC. PATHFINDER2Cleared 510(K)
- K030285MODIFICATION TO TSRH SPINAL SYSTEM2Cleared 510(K)
- NKGPosterior Cervical Screw System2Product Code
- NOVAnchor, Suture, Bone Fixation, Metallic2Product Code
- NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2Product Code
- NQPPosterior Metal/Polymer Spinal System, Fusion2Product Code
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal2Product Code
- NUDVertebroplasty Compound, Calcium Based2Product Code
- NVCBone, Heterograft3Product Code
- NWNLaparoscopic Bone Anchor Urethropexy Instrument Kit2Product Code
- OBLCement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty2Product Code
- OBMCement, Bone, Vertebroplasty, Pre-Formed, Modular2Product Code
- OBTPlate, Bone, Growth Control, Pediatric, Epiphysiodesis2Product Code
- OCGProsthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented3Product Code
- ODPIntervertebral Fusion Device With Bone Graft, Cervical2Product Code
- OISCalcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation2Product Code
- OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive2Product Code
- OJBResorbable Spinal Intervertebral Body Fixation Orthosis - Plate2Product Code
- OJMResorbable Spinal Intervertebral Body Fixation Orthosis - Mesh2Product Code
- OOGKnee Arthroplasty Implantation System2Product Code
- OOLElectronic Depth Gauge2Product Code
- OQBIntervertebral Body Graft Containment Device2Product Code
- OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented2Product Code
- OQHHip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented2Product Code
- OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented2Product Code
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis2Product Code
- OSNSoftware For Diagnosis/Treatment2Product Code
- OURSacroiliac Joint Fixation2Product Code
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar2Product Code
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical2Product Code
- OVZPin, Fixation, Resorbable, Hard Tissue2Product Code
- OWIBone Fixation Cerclage, Sublaminar2Product Code
- OYKAnkle Arthroplasty Implantation System2Product Code
- OZIInternal Hinged Elbow Fixator2Product Code
- PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented2Product Code
- PBFOrthopaedic Surgical Planning And Instrument Guides2Product Code
- PBIProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive2Product Code
- PEKSpinous Process Plate2Product Code
- PHMIntervertebral Fusion Device With Bone Graft, Thoracic2Product Code
- PHQAnterior Staple As Supplemental Fixation For Fusion2Product Code
- PHXShoulder Prosthesis, Reverse Configuration2Product Code
- PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained2Product Code
- PLFBone Wedge2Product Code
- PLRSpinal Vertebral Body Replacement Device - Cervical2Product Code
- PLWAcetabular Cup Orientation System2Product Code
- PMLBone Cement, Posterior Screw Augmentation2Product Code
- PPQTranstibial Anterior Cruciate Ligament Kit2Product Code
- QHQTotal Shoulder Arthroplasty System2Product Code
- PQCPedicle Screw Placement Guide2Product Code
- QACScrew Sleeve Bone Fixation Device2Product Code
- QADRod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated2Product Code
- QFPIntraoperative Orthopedic Strain Sensor2Product Code
- QHEShoulder Arthroplasty Implantation System2Product Code
- QNIResorbable Implant For Anterior Cruciate Ligament (Acl) Repair2Product Code
- QPPImplantable Post-Surgical Kinematic Measurement Knee Device2Product Code
- QPQShoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed2Product Code
- JDJMesh, Surgical, Acetabular, Hip, Prosthesis2Product Code
- JDKProsthesis, Hip, Cement Restrictor2Product Code
- LZNCement Obturator2Product Code
- OLCScaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen2Product Code
- QSDPosterior Cervical Screw Placement Guide2Product Code
- QSRSacroiliac Screw Placement Guide2Product Code
- QVIScrew Sleeve Bone Fixation Device, Spine2Product Code
- QUWMesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament2Product Code
- QWJMesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament2Product Code
- SAIAnkle Fusion Cage2Product Code
- SCYSacroiliac Joint Guidewire Placement Device2Product Code
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Facilis™ Spinal System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K191494
- 510(k) Type
- Special
- Applicant
- Baui Biotech Co., Ltd.
- Country
- Taiwan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/12/2019
- Days to Decision
- 68 days
- Submission Type
- Summary