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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
- 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
- K242928Tesera-k SC System2Cleared 510(K)
- K243188CYLOX® ST2Cleared 510(K)
- K242483Genesys Spine AIS-C II Cervical Interbody Fusion System2Cleared 510(K)
- K242517ProAM ACDF System2Cleared 510(K)
- K241846E3D™-C Interbody System2Cleared 510(K)
- K241467Stable-C Interbody System2Cleared 510(K)
- K240699SCARLET® AC-Ti2Cleared 510(K)
- K234119UniSpace® Stand-Alone C Cage2Cleared 510(K)
- K240715Idys® C ZP 3DTi2Cleared 510(K)
- K233594Genesys Spine 3DP AIS-C II Cervical Interbody System2Cleared 510(K)
- K233414Shoreline ACS Interbody System; Shoreline RT Interbody System2Cleared 510(K)
- K233191TotalTi ACDF by SAGICO2Cleared 510(K)
- K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System2Cleared 510(K)
- K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System2Cleared 510(K)
- K231739Cervical Spine Truss System (CSTS)2Cleared 510(K)
- K223869ChoiceSpine Blackhawk Ti Cervical Spacer System2Cleared 510(K)
- K231763Stable-C Interbody System2Cleared 510(K)
- K230608SPICCA Stand-Alone Cervical Fusion Cages2Cleared 510(K)
- K221138Titus Titanium Cervical by SAGICO2Cleared 510(K)
- K231808QUASAR Standalone ACIF System2Cleared 510(K)
- K223143SAGICO Spinal System2Cleared 510(K)
- K223059Xenco Medical InterAlign Cervical Interbody System2Cleared 510(K)
- K223837SPIRA®-C Integrated Fixation System2Cleared 510(K)
- K222041CYGNUS-C Standalone ACIF System2Cleared 510(K)
- K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device2Cleared 510(K)
- K223105Tesera-K SC System2Cleared 510(K)
- K223140AEON-C™ Stand Alone System2Cleared 510(K)
- K223190Hive™ Standalone Cervical System2Cleared 510(K)
- K222903Tailored-H Cervical Stand Alone System2Cleared 510(K)
- K212612Omnia Medical TiBrid-SC2Cleared 510(K)
- K221578Hexanium ACIF2Cleared 510(K)
- K221049Zavation VariSync Plate System and VariSync Spacer System2Cleared 510(K)
- K213791Unispace SA Cervical Cage2Cleared 510(K)
- K211417F3D-C2 Cervical Stand-Alone System2Cleared 510(K)
- K212358Romero Cervical Cage2Cleared 510(K)
- K212904SeaSpine WaveForm C Interbody System2Cleared 510(K)
- K213359SeaSpine WaveForm, C Interbody System2Cleared 510(K)
- K210573Velofix SA Cervical Cage2Cleared 510(K)
- K212853Cervical Stand-Alone System2Cleared 510(K)
- K212562Idys-C ZP 3DTi2Cleared 510(K)
- K210470C-CURVE Interbody Fusion Device2Cleared 510(K)
- K210382Blustone Synergy Diamond SA Cervical System2Cleared 510(K)
- K211111SureMAX-SA Cervical Standalone System2Cleared 510(K)
- K203311ChoiceSpine Blackhawk Ti Cervical Spacer System2Cleared 510(K)
- K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System2Cleared 510(K)
- K202812IdentiTi Cervical Standalone Interbody System2Cleared 510(K)
- K203076Mecta-C Stand Alone Extension2Cleared 510(K)
- K202065DOLOMITE Anterior Cervical Stabilization System2Cleared 510(K)
- K193000Hexanium® ACIF2Cleared 510(K)
- K200115Cavetto-SA Cervical Cage System2Cleared 510(K)
- K201073Seaspine WaveForm C Interbody System2Cleared 510(K)
- K201646Shoreline ACS (Anterior Cervical System)2Cleared 510(K)
- K200087F3D Cervical Stand-Alone Interbody Fusion System2Cleared 510(K)
- K193153SPIRA-C Integrated Fixation System2Cleared 510(K)
- K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System2Cleared 510(K)
- K192906Mecta-C Stand Alone2Cleared 510(K)
- K192570Atlas Spine Expandable Cervical Standalone Interbody System2Cleared 510(K)
- K191489Genesys Spine 3DP Cervical Interbody System2Cleared 510(K)
- K192582NuVasive CoRoent Small Interlock System2Cleared 510(K)
- K191477AEON-C Stand Alone System2Cleared 510(K)
- K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)2Cleared 510(K)
- K190885Elevation Spine Saber-C System2Cleared 510(K)
- K191565Endoskeleton TCS Interbody Fusion Device2Cleared 510(K)
- K190546NEXXT MATRIXX Stand Alone Cervical System2Cleared 510(K)
- K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System2Cleared 510(K)
- K181621Stable-C Interbody System2Cleared 510(K)
- K182151MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate2Cleared 510(K)
- K181295Genesys Spine AIS-C Cervical Stand-Alone System2Cleared 510(K)
- K180642Pro-Link® Ti Stand-Alone Cervical Spacer System2Cleared 510(K)
- K172484A-CIFT SoloFuse2Cleared 510(K)
- K180056Genesys Spine AIS-C Cervical Anchored Interbody System2Cleared 510(K)
- K173077Cavetto-SA Cervical Cage System2Cleared 510(K)
- K172424Velofix™ SA Cervical Cage2Cleared 510(K)
- K173175Paramount Anterior Cervical Cage System2Cleared 510(K)
- K171489Acapella Cervical Spacer System2Cleared 510(K)
- K170830Unison-C Anterior Cervical Fixation System2Cleared 510(K)
- K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone System2Cleared 510(K)
- K170961NuVasive CoRoent Small Interlock II System2Cleared 510(K)
- K170953Tomcat Cervical Spinal System2Cleared 510(K)
- K163474CAVUX CervicalCage-L SA System2Cleared 510(K)
- K162760Spine Wave Anterior Cervical Spine System2Cleared 510(K)
- K162531STERISPINE CC2Cleared 510(K)
- K162944Irix-C Cervical Integrated Fusion System2Cleared 510(K)
- K160313Xenco Medical Cervical Interbody System2Cleared 510(K)
- K161442NuVasive® CoRoent® Small Interlock™ System2Cleared 510(K)
- K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone System2Cleared 510(K)
- K160066Pro-Link® Stand-Alone Cervical Spacer System2Cleared 510(K)
- K153352Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System2Cleared 510(K)
- K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion System2Cleared 510(K)
- K152622Alta ACDF System2Cleared 510(K)
- K161280Cervical Stand Alone System2Cleared 510(K)
- K153629ArcadiusXP C Spinal System2Cleared 510(K)
- K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System2Cleared 510(K)
- K151939COALITION Spacers2Cleared 510(K)
- K152793Unison-C Anterior Cervical Fixation System2Cleared 510(K)
- K152972Amendia Stand-Alone Cervical System2Cleared 510(K)
- K152515TOMCAT Cervical Spinal System2Cleared 510(K)
- K153122Endoskeleton(r) TCS System2Cleared 510(K)
- K151934ROI-C Titanium-Coated Implant System2Cleared 510(K)
- K151596Endoskeleton TCS Interbody Fusion Device2Cleared 510(K)
- K150765LDR Spine ROI-C Cervical Cage System2Cleared 510(K)
- K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System2Cleared 510(K)
- K151198A-CIFT SoloFuse2Cleared 510(K)
- K150053STALIF C; STALIF C-Ti2Cleared 510(K)
- K150913INCITE ANCHORED CERVICAL INTERBODY DEVICE2Cleared 510(K)
- K143214SCARLET® AC-T Secured Anterior Cervical Cage2Cleared 510(K)
- K142940Endoskeleton TCS System2Cleared 510(K)
- K141599DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM2Cleared 510(K)
- K133218Crystal ®; Mosaic ®; Vertu ®2Cleared 510(K)
- K142299CoRoent Small Interlock System2Cleared 510(K)
- K141537IN:C2 SPINAL FIXATION SYSTME2Cleared 510(K)
- K142079STALIF CTI, STALIF C2Cleared 510(K)
- K141314SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION2Cleared 510(K)
- K141005Z-LINK CERVICAL2Cleared 510(K)
- K133200STALIF C(R)2Cleared 510(K)
- K132999CERVICAL STAND ALONE SYSTEM2Cleared 510(K)
- K132582EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM2Cleared 510(K)
- K132894OPTIO-C ANTERIOR CERVICAL SYSTEM2Cleared 510(K)
- K131880SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM2Cleared 510(K)
- K132029VAULT-C INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K131951IRIX-C CERVICAL INTEGRATED FUSION SYSTEM2Cleared 510(K)
- K131449COALITION SPACER2Cleared 510(K)
- K130306INCITE ANCHORED CERVICAL INTERBODY DEVICE2Cleared 510(K)
- K122771SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM2Cleared 510(K)
- K122630IN:C2 SPINAL FIXATION SYSTEM2Cleared 510(K)
- K122008INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE2Cleared 510(K)
- K121151PRO-LINK CERVICAL SPACER SYSTEM2Cleared 510(K)
- K120819STALIF C2Cleared 510(K)
- K121852SYNTHES ZERO-P VARIABLE ANGLE (VA)2Cleared 510(K)
- K113796SOLITAIRE-C CERVICAL SPACER SYSTEM2Cleared 510(K)
- K113252PEEK PREVAIL CERVICAL INTERBODY DEVICE2Cleared 510(K)
- K112388LANX CERVICAL SA2Cleared 510(K)
- K112459SYNTHES ZERO-P2Cleared 510(K)
- K111272RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM2Cleared 510(K)
- K112068SYNTHES ZERO-P VARIABLE ANGLE (VA)2Cleared 510(K)
- K111439CHESAPEAKE (CERVICAL COMPONENTS)2Cleared 510(K)
- K102606AVS ANCHOR-C CERVICAL CAGE SYSTEM2Cleared 510(K)
- K102547COROENT INTERLOCK SYSTEM2Cleared 510(K)
- K101588ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL2Cleared 510(K)
- K093762SYNTHES ZERO-P2Cleared 510(K)
- K102323CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE2Cleared 510(K)
- K094042PEEK PREVAIL CERVICAL INTERBODY DEVICE2Cleared 510(K)
- K092521ZUMA-C2Cleared 510(K)
- K083389COALITION SPACER2Cleared 510(K)
- K081194INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)2Cleared 510(K)
- K073285PEEK PREVAIL CERVICAL INTERBODY DEVICE2Cleared 510(K)
- K072981SYNTHES ZERO-P2Cleared 510(K)
- K072415STALIF (TM) C2Cleared 510(K)
- K071833MOSAIC DEVICES2Cleared 510(K)
- 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
RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K232348
- 510(k) Type
- Traditional
- Applicant
- MiRus, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/27/2023
- Days to Decision
- 81 days
- Submission Type
- Summary