FDA Product Code
FDA Product Code MQP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3060
510(k) Clearances — 279 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261810 | Vertiwedge® Intraosseous System | Foundation Surgical Group | 2026-07-31 | Special | PDF ↗ |
| K261031 | POSEIDON ST | Signus Medinzintechnik GmbH | 2026-07-10 | Traditional | PDF ↗ |
| K253158 | VyBrate VBR System | Vy Spine, LLC | 2026-01-07 | Traditional | PDF ↗ |
| K241468 | Vertiwedge® Intraosseous System | Foundation Surgical Group, Inc. | 2024-11-07 | Traditional | PDF ↗ |
| K232790 | KONG®-TL VBR System and KONG® C VBR System | Icotec AG | 2024-04-04 | Traditional | PDF ↗ |
| K233359 | DOMINION Expandable Corpectomy System | Astura Medical | 2024-03-08 | Traditional | PDF ↗ |
| K231134 | VerteLoc Spinal System | Signature Orthopaedics Pty, Ltd. | 2024-02-13 | Traditional | PDF ↗ |
| K232173 | Ascend VBR System, Ascend NanoTec VBR System | Alphatec Spine, Inc. | 2023-10-06 | Traditional | PDF ↗ |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) | Arftx Medical, LLC | 2022-10-06 | Traditional | PDF ↗ |
| K202637 | F3D Corpectomy System | Corelink, LLC | 2020-12-23 | Traditional | PDF ↗ |
| K200235 | KONG-TL VBR System, KONG-C VBR System | Icotec AG | 2020-05-29 | Traditional | PDF ↗ |
| K193506 | NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System | Nu Vasive, Incorporated | 2020-02-26 | Special | PDF ↗ |
| K192117 | Small VBR | Ulrich GmbH & Co. KG | 2019-11-01 | Traditional | PDF ↗ |
| K190349 | MediExpand TL Expandable VBR System | Cmf Medicon Surgical, Inc. | 2019-10-24 | Traditional | PDF ↗ |
| K192214 | CarboClear VBR System | CarboFix Orthopedics , Ltd. | 2019-10-11 | Traditional | PDF ↗ |
| K183054 | SYNMESH System | Depuy Synthes Spine | 2019-05-23 | Traditional | PDF ↗ |
| K190147 | COLOSSEUM Mesh | Globus Medical, Inc. | 2019-05-08 | Traditional | PDF ↗ |
| K183197 | PYRAMESH Implant System | Medtronic Sofamor Danek USA, Inc. | 2019-04-04 | Traditional | PDF ↗ |
| K183588 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System | Choicespine | 2019-02-22 | Special | PDF ↗ |
| K183510 | T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2019-01-16 | Special | PDF ↗ |
| K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System | K2m, LLC | 2018-11-28 | Traditional | PDF ↗ |
| K181921 | Solidity Vertebral Body Replacement | Ulrich Medical USA | 2018-11-16 | Traditional | PDF ↗ |
| K181328 | T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2018-09-19 | Traditional | PDF ↗ |
| K173982 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | 2018-09-19 | Traditional | PDF ↗ |
| K173787 | X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System | Medos International SARL | 2018-06-11 | Traditional | PDF ↗ |
| K173800 | Camber Spine Technologies SPIRA - V Open Matrix Corpectomy Cage | Camber Spine Technologies | 2018-02-02 | Traditional | PDF ↗ |
| K172330 | Blustone Synergy Silica System | Blustone Synergy | 2017-12-21 | Traditional | PDF ↗ |
| K173125 | T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek | 2017-12-20 | Traditional | PDF ↗ |
| K162315 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | 2017-11-09 | Traditional | PDF ↗ |
| K172323 | Omnia Medical VBR | Omnia Medical, LLC | 2017-10-26 | Traditional | PDF ↗ |
| K171686 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System | Choicespine | 2017-09-15 | Traditional | PDF ↗ |
| K171704 | CAPRI Corpectomy Cage System | K2m | 2017-08-31 | Traditional | PDF ↗ |
| K162133 | VerteFIT Corpectomy Cage System | Ldr Spine USA, Inc. | 2017-05-16 | Traditional | PDF ↗ |
| K170055 | CAPRI Corpectomy Cage System | K2m | 2017-04-13 | Traditional | PDF ↗ |
| K170271 | NuVasive(r) Monolith Corpectomy System | Nu Vasive, Incorporated | 2017-03-30 | Traditional | PDF ↗ |
| K152460 | Rectangular Corpectomy Cage | Amendia, Inc. | 2015-12-22 | Traditional | PDF ↗ |
| K151538 | NuVasive PEEK Corpectomy Railed System | Nu Vasive, Incorporated | 2015-09-04 | Traditional | PDF ↗ |
| K151167 | NuVasive PEEK Corpectomy System | Nu Vasive, Incorporated | 2015-09-03 | Traditional | PDF ↗ |
| K142005 | SpineFab Vertebral Body Replacement (VBR) System | Oxford Performance Materials | 2015-07-10 | Traditional | PDF ↗ |
| K142205 | NuVasive X-CORE(R) Expandable VBR System | Nuvasive, Inc. | 2015-02-20 | Traditional | PDF ↗ |
| K142996 | StaXx(R) XD System | Spine Wave, Inc. | 2015-02-19 | Traditional | PDF ↗ |
| K143490 | VERTA Corpectomy Cage | Camber Spine | 2015-01-26 | Traditional | PDF ↗ |
| K142030 | STGC-LORDOTIC | Cardinal Spine, LLC | 2015-01-23 | Traditional | PDF ↗ |
| K142016 | CAPRI | K2m, Inc. | 2014-11-06 | Traditional | PDF ↗ |
| K142150 | AIS MODULIFT VBR SYSTEM | Aesculap Implant System, Inc. | 2014-10-29 | Traditional | PDF ↗ |
| K140563 | LATERAL VBR SYSTEM | Nu Vasive, Incorporated | 2014-08-07 | Traditional | PDF ↗ |
| K133802 | AIS MODULIFT VBR SYSTEM | Aesculap Implant System, Inc. | 2014-04-17 | Traditional | PDF ↗ |
| K123758 | TASMIN R | Signus Medizintechnik GmbH | 2014-01-14 | Traditional | PDF ↗ |
| K131724 | PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE | Pioneer Surgical Technology, Inc. | 2013-12-24 | Traditional | PDF ↗ |
| K133207 | STAXX(R) SYSTEM | Spine Wave, Inc. | 2013-12-06 | Special | PDF ↗ |
| K131888 | T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE | Medtronic Sofamor Danek, Inc. | 2013-09-23 | Traditional | PDF ↗ |
| K122622 | ENDURAMESH | Lucero Medical, LLC | 2012-09-19 | Special | PDF ↗ |
| K121889 | STAXX XD SYSTEM | Spine Wave, Inc. | 2012-08-29 | Special | PDF ↗ |
| K121176 | STGC | Cardinal Spine, LLC | 2012-08-17 | Traditional | PDF ↗ |
| K121107 | FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R) | Globus Medical, Inc. | 2012-07-03 | Special | PDF ↗ |
| K120570 | CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM | Choicespine, LP | 2012-04-05 | Traditional | PDF ↗ |
| K111294 | SANTORINI SPINAL SYSTEM | K2m, Inc. | 2012-01-27 | Traditional | PDF ↗ |
| K112429 | GIZA(R) VERTEBRAL BODY REPLACEMENT | Eden Spine, LLC | 2012-01-26 | Traditional | PDF ↗ |
| K111418 | STAXX(R) XD SYSTEM | Spine Wave, Inc. | 2011-12-13 | Traditional | PDF ↗ |
| K103320 | SYNTHES XRL | Synthes Spine Co.Lp | 2011-10-20 | Traditional | PDF ↗ |
| K110153 | SFC VERTEBRAL BODY REPLACEMENT | Konigsee Implantate GmbH | 2011-10-12 | Traditional | PDF ↗ |
| K112756 | FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS | Globus Medical, Inc. | 2011-10-07 | Special | PDF ↗ |
| K102315 | STAXX XDL SYSTEM | Spine Wave, Inc. | 2011-08-19 | Traditional | PDF ↗ |
| K101886 | DSC/ALF SPINAL SYSTEM | Sintea Plastek, LLC | 2011-07-21 | Traditional | PDF ↗ |
| K111469 | STAXXSD SYSTEM | Spine Wave, Inc. | 2011-07-19 | Special | PDF ↗ |
| K110864 | BIOSPINE VBR SYSTEM | Aesculap Implant Systems, LLC | 2011-06-15 | Traditional | PDF ↗ |
| K102682 | STAXX(R) XD SYSTEM | Spine Wave, Inc. | 2010-11-30 | Special | PDF ↗ |
| K100976 | T2 XVBR 1.5 SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2010-10-21 | Traditional | PDF ↗ |
| K101288 | STAXX XD SYSTEM | Spine Wave, Inc. | 2010-09-10 | Traditional | PDF ↗ |
| K093207 | ENDURAMESH, MODEL 762.XXX | Lucero Medical, LLC | 2010-04-26 | Traditional | PDF ↗ |
| K093127 | TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET | Zimmer Trabecular Metal Technology | 2010-03-04 | Traditional | PDF ↗ |
| K083186 | AESCULAP HYDROLIFT VBR SYSTEM | Aesculap Implant System, Inc. | 2010-03-04 | Traditional | PDF ↗ |
| K091426 | CERVICORE CORPECTOMY CAGE | Verticor, Ltd. | 2009-12-23 | Traditional | PDF ↗ |
| K091743 | SEC VBR | Innvotec Surgical, Inc. | 2009-11-02 | Traditional | PDF ↗ |
| K092336 | C-THRU SPINAL SYSTEM | Ebi, L.P. | 2009-10-15 | Traditional | PDF ↗ |
| K090841 | ADDPLUS | Ulrich GmbH & Co. KG | 2009-10-05 | Traditional | PDF ↗ |
| K091946 | VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX | Stryker Spine | 2009-09-25 | Traditional | PDF ↗ |
| K091883 | T2 SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2009-09-21 | Traditional | PDF ↗ |
| K091406 | ATLAS SPINE SPACER | Atlas Spine, LLC | 2009-09-04 | Traditional | PDF ↗ |
| K090315 | STAXX XD SYSTEM | Spine Wave, Inc. | 2009-09-03 | Traditional | PDF ↗ |
| K090176 | NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM | Nuvasive, Inc. | 2009-04-27 | Special | PDF ↗ |
| K083857 | LDR SPINE ROI-C IMPLANT | Ldr Spine USA | 2009-02-12 | Special | PDF ↗ |
| K082466 | XYCOR SPINAL IMPLANT | Vertebration,Inc | 2009-01-09 | Traditional | PDF ↗ |
| K082112 | T2 XVBR SPINAL SYSTEM | Medtronic Sofamor Danek | 2008-08-27 | Special | PDF ↗ |
| K080971 | SPINESMITH CIMPLICITY SPINAL SYSTEM | Spine Smith Partners L.P. | 2008-07-02 | Traditional | PDF ↗ |
| K081383 | RELIANCE VBS SYSTEM | Reliance Medical Systems, LLC | 2008-07-02 | Special | PDF ↗ |
| K081564 | CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION | Creaspine | 2008-06-30 | Special | PDF ↗ |
| K072326 | OSTAPEK VBR SYSTEM | Co-Ligne AG | 2008-06-24 | Traditional | PDF ↗ |
| K081332 | ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM | Signus Medizintechnik GmbH | 2008-06-10 | Special | PDF ↗ |
| K080860 | CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM | Creaspine | 2008-05-29 | Traditional | PDF ↗ |
| K080728 | LDR SPINE ROI-C IMPLANT | Ldr Spine USA | 2008-05-29 | Special | PDF ↗ |
| K080699 | NOVEL SPINAL SPACER SYSTEM | Alphatec Spine, Inc. | 2008-05-21 | Traditional | PDF ↗ |
| K080569 | LDR SPINE ROI-T IMPLANT | Ldr Spine USA | 2008-05-07 | Special | PDF ↗ |
| K080568 | X-MESH EXPANDABLE CAGE SYSTEM | Depuy Spine, Inc. | 2008-05-01 | Special | PDF ↗ |
| K080572 | LDR SPINE ROI-A IMPLANT | Ldr Spine USA | 2008-04-07 | Special | PDF ↗ |
| K073502 | VERTEBRON VBR SYSTEM | Vertebron, Inc. | 2008-03-24 | Traditional | PDF ↗ |
| K080349 | KIMBA MINI | Signus Medizintechnik GmbH | 2008-03-10 | Special | PDF ↗ |
| K073649 | BENGAL STACKABLE CAGE SYSTEM | Depuy Spine, Inc. | 2008-01-25 | Special | PDF ↗ |
| K080024 | ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01 | K2m, Inc. | 2008-01-24 | Special | PDF ↗ |
| K073505 | MODIFICATION TO VALEO VBR | Amedica Corp. | 2008-01-09 | Special | PDF ↗ |
Product code MQP · Class II · Orthopedic. Data: openFDA.