Anesthesiology
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- Gastroenterology and UrologyReview Panel
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- ImmunologyReview Panel
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- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- 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
- K243905Stitch Cerclage – Suture Tapes2Cleared 510(K)
- K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures2Cleared 510(K)
- K232733Mbrace Cable2Cleared 510(K)
- K233949ACCORD Cable System2Cleared 510(K)
- K232986VariTrax Sternal CircumFixation System2Cleared 510(K)
- K230976Arthrex Radiopaque FiberTape Cerclage sutures2Cleared 510(K)
- K231333STRETTO™ Cable System2Cleared 510(K)
- K220765HS Fiber Cerclage2Cleared 510(K)
- K221795STERN FIX Sternal Stabilization System2Cleared 510(K)
- K211613Stern Fix Sternal Stabilization System2Cleared 510(K)
- K201497EVOS Cabling System2Cleared 510(K)
- K202016Dall-Miles® Cable System2Cleared 510(K)
- K193479Sternal Cable System2Cleared 510(K)
- K193468Tritium Sternal Cable Plate System2Cleared 510(K)
- K181607Thorecon Rigid Fixation System2Cleared 510(K)
- K173910Impress SFS System2Cleared 510(K)
- K181749SuperCable® Iso-Elastic™ Cerclage System2Cleared 510(K)
- K172975DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional2Cleared 510(K)
- K180582Sternal Cable System2Cleared 510(K)
- K173579Thorecon™ Fixation System2Cleared 510(K)
- K170206Arthrex FiberTape Cerclage2Cleared 510(K)
- K161876Tritium® Sternal Cable Plate System2Cleared 510(K)
- K151983KLS Martin LSS Plating System2Cleared 510(K)
- K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System2Cleared 510(K)
- K153242Frontier Medical Devices In-Line Orthopedic Cable Cerclage System2Cleared 510(K)
- K151888Frontier Medical Devices In-line Orthopedic Cable Cerclage System2Cleared 510(K)
- K143716DSM Biomedical DPR Cable2Cleared 510(K)
- K151346Frontier Medical Devices Posterior Cable Screw System2Cleared 510(K)
- K150889Suture Wires and Wire Loops2Cleared 510(K)
- K150581Tritium Sternal Cable Plate System2Cleared 510(K)
- K133785TRITIUM STERNAL CABLE PLATE SYSTEM2Cleared 510(K)
- K133354PERI-PROSTHETIC CABLE SYSTEM2Cleared 510(K)
- K130431COMPRESSYN BAND2Cleared 510(K)
- K121541JAZZ SYSTEM2Cleared 510(K)
- K120177SPINAL ELEMENTS CERCLAGE SYSTEM2Cleared 510(K)
- K112736PASS LP SPINAL2Cleared 510(K)
- K110789SYNTHES STERNAL ZIPFIX SYSTEM2Cleared 510(K)
- K110541FIGURE 8 STERNOTOMY CLOSURE DEVICE2Cleared 510(K)
- K103797K2M COCR WIRE2Cleared 510(K)
- K110039BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM2Cleared 510(K)
- K101484COMPRESSYN BAND2Cleared 510(K)
- K102834ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)2Cleared 510(K)
- K090686SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS2Cleared 510(K)
- K091190UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-300632Cleared 510(K)
- K081622UNIVERSAL CLAMP STAINLESS STEEL SYSTEM2Cleared 510(K)
- K081205SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS2Cleared 510(K)
- K071271BIOMET CABLE SYSTEM2Cleared 510(K)
- K063017AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM2Cleared 510(K)
- K060009ABBOTT SPINE UNIVERSAL CLAMP SYSTEM2Cleared 510(K)
- K050041SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM2Cleared 510(K)
- K043252CABLING SYSTEM TROCHANTER HOOK2Cleared 510(K)
- K033816SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM2Cleared 510(K)
- K040199OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS2Cleared 510(K)
- K030256ISO-ELASTIC CERCLAGE SYSTEM2Cleared 510(K)
- K031508SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM2Cleared 510(K)
- K031162SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM2Cleared 510(K)
- K023564OSSE-LIGN2Cleared 510(K)
- K010943SYNTHES STERNAL FIXATION SYSTEM2Cleared 510(K)
- K003951PECTOFIX STERNAL REPAIR WIRE2Cleared 510(K)
- K001254ORTHOMATRIX, INC. CERCLAGE SYSTEM2Cleared 510(K)
- K002110SPL CRIMP SYSTEM2Cleared 510(K)
- K001709TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-0672Cleared 510(K)
- K000694PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)2Cleared 510(K)
- K993903WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-10132Cleared 510(K)
- K993286PIONEER SILICOAT STERNAL CABLE2Cleared 510(K)
- K992891SYNTHES CERCLAGE POSITIONING PIN2Cleared 510(K)
- K992616SDB CERCLAGE SYSTEM2Cleared 510(K)
- K984432DALL-MILES CABLE GRIP (A-GRIP)2Cleared 510(K)
- K983976METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM2Cleared 510(K)
- K982545BMP CABLE SYSTEM2Cleared 510(K)
- K980690CABLE SCREW WITH INTEGRAL CRIMP2Cleared 510(K)
- K974016CERCLAGE CABLE WITH HEX BUTTON2Cleared 510(K)
- K974020SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM2Cleared 510(K)
- K973098COMPRESSION CERCLAGE GUNDOLF CCG-GF2Cleared 510(K)
- K972327METAGEN ACTIVELOCK CERCLAGE SYSTEM2Cleared 510(K)
- K971741DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE2Cleared 510(K)
- K970084LINK CERCLAGE WIRE SYSTEM2Cleared 510(K)
- K962162DALL-MILES TROCHANTER CABLE SUPERGRIP2Cleared 510(K)
- K962132SILKON STAINLESS STEEL CABLE SYSTEM2Cleared 510(K)
- K961267PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE2Cleared 510(K)
- K961569DALL-MILES STAINLESS STEEL BEADED CABLE2Cleared 510(K)
- K961283DALL-MILES HOMOGENOUS VITALLIUM CABLE2Cleared 510(K)
- K960651CERCLAGE WIRE CRIMP BLOCK2Cleared 510(K)
- K953777SYNTHES WIRE MOUNT2Cleared 510(K)
- K953818DALL-MILES SUTURE/BEADED CABLE2Cleared 510(K)
- K951844BIOMECHANIC LOW-PROFILE CABLE SYSTEM2Cleared 510(K)
- K945294DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE2Cleared 510(K)
- K950027CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK2Cleared 510(K)
- K944529CABLE-EASE PLATE AND CABLE SYSTEM2Cleared 510(K)
- K932024CCG CERCLAGE SYSTEM2Cleared 510(K)
- K942300SILKON TITANIUM CABLE SYSTEM2Cleared 510(K)
- K940729PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES2Cleared 510(K)
- K934059DALL MILES SYSTEM GROOVED BUTTON2Cleared 510(K)
- K932687AME(R) UNIVERSIAL CABLE SYSTEM2Cleared 510(K)
- K941213SONGER CABLE SYSTEM2Cleared 510(K)
- K935950FX-CABLELOK CABLE/PLATE SYSTEM2Cleared 510(K)
- K935646FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM2Cleared 510(K)
- K934557CONTROL CABLE SYSTEM2Cleared 510(K)
- K934058DALL MILES SYSTEM MINICLEAT2Cleared 510(K)
- K934176SURGICAL ACCESSORIES LOOPED WIRE2Cleared 510(K)
- K931246CERCLAGE WIRE CRIMP SLEEVE2Cleared 510(K)
- K935592SURGICAL ACCESSORIES COCR CABLE SYSTEM2Cleared 510(K)
- K935481SPONGER CABLE SYSTEM, MODIFICATION2Cleared 510(K)
- K924141ORTHOPAEDIC POLYETHYLENE CABLE2Cleared 510(K)
- K925447OTI ORTHOPEDIC WIRE SYSTEM2Cleared 510(K)
- K930015STERNAL BAND2Cleared 510(K)
- K923869CODMAN SOF'WIRE TITANIUM CABLE SYSTEM2Cleared 510(K)
- K926116CODMAN SOFWIRE(TM) KIT2Cleared 510(K)
- K925812TITANIUM SONGER CABLE SYSTEM2Cleared 510(K)
- K922952SONGER CABLE SYSTEM2Cleared 510(K)
- K922142FX-CABLELOK SYSTEM2Cleared 510(K)
- K921480OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM2Cleared 510(K)
- K920201TITANIUM ALLOY SONGER CABLE SYSTEM2Cleared 510(K)
- K915259FX-CABLELOK SYSTEM, MODIFICATION2Cleared 510(K)
- K915581CODMAN SOF'WIRE (TM) KIT2Cleared 510(K)
- K914374OSTEO CERCLAGE WIRE2Cleared 510(K)
- K914693DEPUY (NITINO) GUIDE WIRE2Cleared 510(K)
- K913735SONGER(TM) CABLE SYSTEM2Cleared 510(K)
- K912207FX-CABLELOK SYSTEM2Cleared 510(K)
- K910128LEVTECH TITANIUM BONE WIRE2Cleared 510(K)
- K903676STERNOTOMY CABLE, SONGER CABLE SYSTEM2Cleared 510(K)
- K892411MENNEN BONE FIXATION DEVICE2Cleared 510(K)
- K882967BONE FIXATION WIRE2Cleared 510(K)
- K882890WROBLEWSKI SPRING COMPRESSION WIRE SYSTEM2Cleared 510(K)
- K880309TYPE 316L STAINLESS STEEL WIRE2Cleared 510(K)
- K875156STAINLESS STEEL ORTHOPAEDIC CABLE SYSTEM2Cleared 510(K)
- K874919ORTHOMET WIRE FOR SUTURE, CERCLAGE2Cleared 510(K)
- K850631KIRSCHNER ORTHOPEDIC WIRE, EYELET CERCLAGE WIRES2Cleared 510(K)
- K842977ORTHOPAEDIC CABLE SYSTEM2Cleared 510(K)
- 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
- 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
Tritium Sternal Cable Plate System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K193468
- 510(k) Type
- Traditional
- Applicant
- Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/12/2020
- Days to Decision
- 87 days
- Submission Type
- Summary