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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
- NKGPosterior Cervical Screw System2Product Code
- K250332Virage® OCT Spinal Fixation System2Cleared 510(K)
- K242516EUROPA™ Posterior Cervical Fusion System2Cleared 510(K)
- K233989CarboClear® Posterior Cervical Screw System2Cleared 510(K)
- K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments2Cleared 510(K)
- K233332Statera-C™ Spinal System2Cleared 510(K)
- K233078Posterior Cervical Spine System2Cleared 510(K)
- K233366SYMPHONY OCT System2Cleared 510(K)
- K232167VySpan™ PCT System2Cleared 510(K)
- K231654NorthStar OCT System2Cleared 510(K)
- K231840CastleLoc-S Posterior Cervical Fixation System2Cleared 510(K)
- K221307Edge Upper Cervical System2Cleared 510(K)
- K230614Cortium™2Cleared 510(K)
- K223852VySpan™ PCT System2Cleared 510(K)
- K223764INFINITY OCT System2Cleared 510(K)
- K220658COSY Cervicothoracic Occipital Rod-Screw System2Cleared 510(K)
- K222107Black Diamond™ POCT Spinal System2Cleared 510(K)
- K221388NuVasive Reline Cervical System2Cleared 510(K)
- K213871Ennovate Cervical Spinal and Occiput System2Cleared 510(K)
- K220570M.U.S.T. MINI Posterior Cervical Screws System Extension2Cleared 510(K)
- K220810Infinity™ OCT System and PASS OCT Spinal System2Cleared 510(K)
- K213654NuVasive Reline Cervical System2Cleared 510(K)
- K213394Vy Spine™ VySpan™ PCT System2Cleared 510(K)
- K210887Altus Spine Sochi OCT Spinal System2Cleared 510(K)
- K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments2Cleared 510(K)
- K211993Z-LINKPC System2Cleared 510(K)
- K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System2Cleared 510(K)
- K210449Infinity™ OCT System, PASS OCT® Spinal System2Cleared 510(K)
- K203319SYMPHONY™ OCT System2Cleared 510(K)
- K203125Invictus™ OCT Spinal Fixation System2Cleared 510(K)
- K203149M.U.S.T. MINI Posterior Cervical Screws System2Cleared 510(K)
- K200793LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System2Cleared 510(K)
- K201481Centurion POCT System2Cleared 510(K)
- K200936Invictus™ CT Spinal Fixation System2Cleared 510(K)
- K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation System2Cleared 510(K)
- K200896Solstice CCI2Cleared 510(K)
- K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation System2Cleared 510(K)
- K192013VERTICALE® Cervical System2Cleared 510(K)
- K192646SYMPHONY™ OCT System2Cleared 510(K)
- K193615NorthStar™ OCT Spinal System2Cleared 510(K)
- K200130M.U.S.T. MINI Posterior Cervical Screws System2Cleared 510(K)
- K193129Yukon OCT Spinal System2Cleared 510(K)
- K192014SYPMHONY™ OCT System2Cleared 510(K)
- K192354Innovasis Gibralt Spine System2Cleared 510(K)
- K191553NuVaisve® Reline® Cervical System2Cleared 510(K)
- K190895MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System2Cleared 510(K)
- K191185Solanas® Posterior OCT Fixation System2Cleared 510(K)
- K190751Connector System2Cleared 510(K)
- K190631M.U.S.T. MINI Posterior Cervical Screws System2Cleared 510(K)
- K190071Perla® Posterior Cervico-Thoracic Fixation System2Cleared 510(K)
- K182837M.U.S.T. Mini Extension2Cleared 510(K)
- K183383ANAX™ OCT Spinal System2Cleared 510(K)
- K182182YUKON OCT Spinal System2Cleared 510(K)
- K182508Saxxony™ Posterior Cervical Thoracic System2Cleared 510(K)
- K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System2Cleared 510(K)
- K181949SYMPHONY™ OCT System2Cleared 510(K)
- K181440Proficient® Posterior Cervical Spine System2Cleared 510(K)
- K181350ASTRA-OCT Spine System2Cleared 510(K)
- K180851VERTEX™ Reconstruction System2Cleared 510(K)
- K172495Reform® POCT System2Cleared 510(K)
- K180198NuVasive® VuePoint® II OCT System2Cleared 510(K)
- K173047The Solstice OCT System2Cleared 510(K)
- K180025Centurion POCT System2Cleared 510(K)
- K171834G Surgical OCT Spinal System2Cleared 510(K)
- K172594Proficient® Posterior Cervical Spine System2Cleared 510(K)
- K171250BRIDALVEIL Occipital Cervical Thoracic System2Cleared 510(K)
- K172279PMT Posterior Fixation System2Cleared 510(K)
- K163375INFINITY™ OCT System2Cleared 510(K)
- K172194Connector System2Cleared 510(K)
- K172139Streamline OCT Occipito-Cervico-Thoracic System2Cleared 510(K)
- K171444YUKON OCT Spinal System2Cleared 510(K)
- K171369M.U.S.T. MINI Posterior Cervical Screws System2Cleared 510(K)
- K170804The Solstice OCT System2Cleared 510(K)
- K170647Connector System2Cleared 510(K)
- K162266The Cranial Fusion System2Cleared 510(K)
- K162575Z-LINKPC System2Cleared 510(K)
- K162639Proficient™ Posterior Cervical Spine System2Cleared 510(K)
- K161637Poseidon OCT Spinal Fixation System2Cleared 510(K)
- K161032neon3™ universal OCT spinal stabilization2Cleared 510(K)
- K162300Reform® POCT System2Cleared 510(K)
- K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System2Cleared 510(K)
- K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments2Cleared 510(K)
- K161478Xenco Medical Posterior Cervical System2Cleared 510(K)
- K161498Streamline OCT Occipito-Cervico-Thoracic System2Cleared 510(K)
- K153439PathLoc-C Posterior Cervical Fixation System2Cleared 510(K)
- K161149PASS OCT Spinal System2Cleared 510(K)
- K160697Gibralt® Spine System and Gibralt® Occipital Spine System2Cleared 510(K)
- K160428Certex Spinal Fixation System2Cleared 510(K)
- K160756PASS OCT Spinal System2Cleared 510(K)
- K153631Zimmer Virage OCT Spinal Fixation System2Cleared 510(K)
- K153370Caspian OCT/MESA Mini/DENALI Mini Spinal System2Cleared 510(K)
- K153169PASS OCT Patient Specific Rods2Cleared 510(K)
- K153386Perla Posterior Cervico-Thoracic Fixation system2Cleared 510(K)
- K153336VuePoint OCT System2Cleared 510(K)
- K152211PCT System2Cleared 510(K)
- K152338VERTEX(r) Reconstruction System2Cleared 510(K)
- K151938S4 Cervical Spinal and Occiput Systems2Cleared 510(K)
- K150474NuVasive VuePoint II OCT System2Cleared 510(K)
- K150918PASS OCT Spinal System2Cleared 510(K)
- K150650neon32Cleared 510(K)
- K151885SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System2Cleared 510(K)
- K151705Lotus Posterior Cervical/Thoracic Spinal System2Cleared 510(K)
- K151755OASYS(r) System2Cleared 510(K)
- K151224Lineum OCT Spine System2Cleared 510(K)
- K151031Virage OCT Spinal Fixation System2Cleared 510(K)
- K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS2Cleared 510(K)
- K150570ANAX OCT Spinal System2Cleared 510(K)
- K150822Centurion POCT System2Cleared 510(K)
- K150539OASYS System2Cleared 510(K)
- K143471VERTEX Reconstruction System2Cleared 510(K)
- K142838Synapse Occipital-Cervical-Thoracic (OCT) System2Cleared 510(K)
- 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
Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K211710
- 510(k) Type
- Traditional
- Applicant
- Orthofix Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/30/2021
- Days to Decision
- 57 days
- Submission Type
- Summary