MQP · Spinal Vertebral Body Replacement Device
Orthopedic · 21 CFR 888.3060 · Class 2
Overview
| Product Code | MQP |
|---|---|
| Device Name | Spinal Vertebral Body Replacement Device |
| Regulation | 21 CFR 888.3060 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.
Classification Rationale
Class II.
Cleared Devices (277)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253158 | VyBrate VBR System | Vy Spine, LLC | Jan 7, 2026 | SESE |
| K241468 | Vertiwedge® Intraosseous System | Foundation Surgical Group, Inc. | Nov 7, 2024 | SESE |
| K232790 | KONG®-TL VBR System and KONG® C VBR System | Icotec AG | Apr 4, 2024 | SESE |
| K233359 | DOMINION Expandable Corpectomy System | Astura Medical | Mar 8, 2024 | SESE |
| K231134 | VerteLoc Spinal System | Signature Orthopaedics Pty, Ltd. | Feb 13, 2024 | SESE |
| K232173 | Ascend VBR System, Ascend NanoTec VBR System | Alphatec Spine, Inc. | Oct 6, 2023 | SESE |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) | Arftx Medical, LLC | Oct 6, 2022 | SESE |
| K202637 | F3D Corpectomy System | Corelink, LLC | Dec 23, 2020 | SESE |
| K200235 | KONG-TL VBR System, KONG-C VBR System | Icotec AG | May 29, 2020 | SESE |
| K193506 | NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System | Nu Vasive, Incorporated | Feb 26, 2020 | SESE |
| K192117 | Small VBR | Ulrich GmbH & Co. KG | Nov 1, 2019 | SESE |
| K190349 | MediExpand TL Expandable VBR System | Cmf Medicon Surgical, Inc. | Oct 24, 2019 | SESE |
| K192214 | CarboClear VBR System | CarboFix Orthopedics , Ltd. | Oct 11, 2019 | SESE |
| K183054 | SYNMESH System | Depuy Synthes Spine | May 23, 2019 | SESE |
| K190147 | COLOSSEUM Mesh | Globus Medical, Inc. | May 8, 2019 | SESE |
| K183197 | PYRAMESH Implant System | Medtronic Sofamor Danek USA, Inc. | Apr 4, 2019 | SESE |
| K183588 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System | Choicespine | Feb 22, 2019 | SESE |
| K183510 | T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | Jan 16, 2019 | SESE |
| K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System | K2m, LLC | Nov 28, 2018 | SESE |
| K181921 | Solidity Vertebral Body Replacement | Ulrich Medical USA | Nov 16, 2018 | SESE |
| K181328 | T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | Sep 19, 2018 | SESE |
| K173982 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | Sep 19, 2018 | SESE |
| 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 | Jun 11, 2018 | SESE |
| K173800 | Camber Spine Technologies SPIRA - V Open Matrix Corpectomy Cage | Camber Spine Technologies | Feb 2, 2018 | SESE |
| K172330 | Blustone Synergy Silica System | Blustone Synergy | Dec 21, 2017 | SESE |
| K173125 | T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek | Dec 20, 2017 | SESE |
| K162315 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | Nov 9, 2017 | SESE |
| K172323 | Omnia Medical VBR | Omnia Medical, LLC | Oct 26, 2017 | SESE |
| K171686 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System | Choicespine | Sep 15, 2017 | SESE |
| K171704 | CAPRI Corpectomy Cage System | K2m | Aug 31, 2017 | SESE |
| K162133 | VerteFIT Corpectomy Cage System | Ldr Spine USA, Inc. | May 16, 2017 | SESE |
| K170055 | CAPRI Corpectomy Cage System | K2m | Apr 13, 2017 | SESE |
| K170271 | NuVasive(r) Monolith Corpectomy System | Nu Vasive, Incorporated | Mar 30, 2017 | SESE |
| K152460 | Rectangular Corpectomy Cage | Amendia, Inc. | Dec 22, 2015 | SESE |
| K151538 | NuVasive PEEK Corpectomy Railed System | Nu Vasive, Incorporated | Sep 4, 2015 | SESE |
| K151167 | NuVasive PEEK Corpectomy System | Nu Vasive, Incorporated | Sep 3, 2015 | SESE |
| K142005 | SpineFab Vertebral Body Replacement (VBR) System | Oxford Performance Materials | Jul 10, 2015 | SESE |
| K142205 | NuVasive X-CORE(R) Expandable VBR System | Nuvasive, Inc. | Feb 20, 2015 | SESE |
| K142996 | StaXx(R) XD System | Spine Wave, Inc. | Feb 19, 2015 | SESE |
| K143490 | VERTA Corpectomy Cage | Camber Spine | Jan 26, 2015 | SESE |
| K142030 | STGC-LORDOTIC | Cardinal Spine, LLC | Jan 23, 2015 | SESE |
| K142016 | CAPRI | K2m, Inc. | Nov 6, 2014 | SESE |
| K142150 | AIS MODULIFT VBR SYSTEM | Aesculap Implant System, Inc. | Oct 29, 2014 | SESE |
| K140563 | LATERAL VBR SYSTEM | Nu Vasive, Incorporated | Aug 7, 2014 | SESE |
| K133802 | AIS MODULIFT VBR SYSTEM | Aesculap Implant System, Inc. | Apr 17, 2014 | SESE |
| K123758 | TASMIN R | Signus Medizintechnik GmbH | Jan 14, 2014 | SESE |
| K131724 | PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE | Pioneer Surgical Technology, Inc. | Dec 24, 2013 | SESE |
| K133207 | STAXX(R) SYSTEM | Spine Wave, Inc. | Dec 6, 2013 | SESE |
| K131888 | T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE | Medtronic Sofamor Danek, Inc. | Sep 23, 2013 | SESE |
| K122622 | ENDURAMESH | Lucero Medical, LLC | Sep 19, 2012 | SESE |
| K121889 | STAXX XD SYSTEM | Spine Wave, Inc. | Aug 29, 2012 | SESE |
| K121176 | STGC | Cardinal Spine, LLC | Aug 17, 2012 | SESE |
| K121107 | FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R) | Globus Medical, Inc. | Jul 3, 2012 | SESE |
| K120570 | CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM | Choicespine, LP | Apr 5, 2012 | SESE |
| K111294 | SANTORINI SPINAL SYSTEM | K2m, Inc. | Jan 27, 2012 | SESE |
| K112429 | GIZA(R) VERTEBRAL BODY REPLACEMENT | Eden Spine, LLC | Jan 26, 2012 | SESE |
| K111418 | STAXX(R) XD SYSTEM | Spine Wave, Inc. | Dec 13, 2011 | SESE |
| K103320 | SYNTHES XRL | Synthes Spine Co.Lp | Oct 20, 2011 | SESE |
| K110153 | SFC VERTEBRAL BODY REPLACEMENT | Konigsee Implantate GmbH | Oct 12, 2011 | SESE |
| K112756 | FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS | Globus Medical, Inc. | Oct 7, 2011 | SESE |
| K102315 | STAXX XDL SYSTEM | Spine Wave, Inc. | Aug 19, 2011 | SESE |
| K101886 | DSC/ALF SPINAL SYSTEM | Sintea Plastek, LLC | Jul 21, 2011 | SESE |
| K111469 | STAXXSD SYSTEM | Spine Wave, Inc. | Jul 19, 2011 | SESE |
| K110864 | BIOSPINE VBR SYSTEM | Aesculap Implant Systems, LLC | Jun 15, 2011 | SESE |
| K102682 | STAXX(R) XD SYSTEM | Spine Wave, Inc. | Nov 30, 2010 | SESE |
| K100976 | T2 XVBR 1.5 SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | Oct 21, 2010 | SESE |
| K101288 | STAXX XD SYSTEM | Spine Wave, Inc. | Sep 10, 2010 | SESE |
| K093207 | ENDURAMESH, MODEL 762.XXX | Lucero Medical, LLC | Apr 26, 2010 | SESE |
| K093127 | TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET | Zimmer Trabecular Metal Technology | Mar 4, 2010 | SESE |
| K083186 | AESCULAP HYDROLIFT VBR SYSTEM | Aesculap Implant System, Inc. | Mar 4, 2010 | SESE |
| K091426 | CERVICORE CORPECTOMY CAGE | Verticor, Ltd. | Dec 23, 2009 | SESE |
| K091743 | SEC VBR | Innvotec Surgical, Inc. | Nov 2, 2009 | SESE |
| K092336 | C-THRU SPINAL SYSTEM | Ebi, L.P. | Oct 15, 2009 | SESE |
| K090841 | ADDPLUS | Ulrich GmbH & Co. KG | Oct 5, 2009 | SESE |
| K091946 | VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX | Stryker Spine | Sep 25, 2009 | SESE |
| K091883 | T2 SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | Sep 21, 2009 | SESE |
| K091406 | ATLAS SPINE SPACER | Atlas Spine, LLC | Sep 4, 2009 | SESE |
| K090315 | STAXX XD SYSTEM | Spine Wave, Inc. | Sep 3, 2009 | SESE |
| K090176 | NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM | Nuvasive, Inc. | Apr 27, 2009 | SESE |
| K083857 | LDR SPINE ROI-C IMPLANT | Ldr Spine USA | Feb 12, 2009 | SESE |
| K082466 | XYCOR SPINAL IMPLANT | Vertebration,Inc | Jan 9, 2009 | SESE |
| K082112 | T2 XVBR SPINAL SYSTEM | Medtronic Sofamor Danek | Aug 27, 2008 | SESE |
| K081383 | RELIANCE VBS SYSTEM | Reliance Medical Systems, LLC | Jul 2, 2008 | SESE |
| K080971 | SPINESMITH CIMPLICITY SPINAL SYSTEM | Spine Smith Partners L.P. | Jul 2, 2008 | SESE |
| K081564 | CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION | Creaspine | Jun 30, 2008 | SESE |
| K072326 | OSTAPEK VBR SYSTEM | Co-Ligne AG | Jun 24, 2008 | SESE |
| K081332 | ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM | Signus Medizintechnik GmbH | Jun 10, 2008 | SESE |
| K080860 | CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM | Creaspine | May 29, 2008 | SESE |
| K080728 | LDR SPINE ROI-C IMPLANT | Ldr Spine USA | May 29, 2008 | SESE |
| K080699 | NOVEL SPINAL SPACER SYSTEM | Alphatec Spine, Inc. | May 21, 2008 | SESE |
| K080569 | LDR SPINE ROI-T IMPLANT | Ldr Spine USA | May 7, 2008 | SESE |
| K080568 | X-MESH EXPANDABLE CAGE SYSTEM | Depuy Spine, Inc. | May 1, 2008 | SESE |
| K080572 | LDR SPINE ROI-A IMPLANT | Ldr Spine USA | Apr 7, 2008 | SESE |
| K073502 | VERTEBRON VBR SYSTEM | Vertebron, Inc. | Mar 24, 2008 | SESE |
| K080349 | KIMBA MINI | Signus Medizintechnik GmbH | Mar 10, 2008 | SESE |
| K073649 | BENGAL STACKABLE CAGE SYSTEM | Depuy Spine, Inc. | Jan 25, 2008 | SESE |
| K080024 | ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01 | K2m, Inc. | Jan 24, 2008 | SESE |
| K073505 | MODIFICATION TO VALEO VBR | Amedica Corp. | Jan 9, 2008 | SESE |
| K072537 | CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM | Creaspine Sas | Dec 18, 2007 | SESE |
| K073125 | VALEO VBR | Amedica Corp. | Dec 5, 2007 | SESE |
| K071726 | ZUMA | Seaspine, Inc. | Oct 23, 2007 | SESE |
| K072029 | PHENIX VERTEBRAL BODY REPLACEMENT | New Business Development, LLC | Oct 15, 2007 | SESE |
| K072465 | NIKO CORPECTOMY SPACER | Globus Medical, Inc. | Oct 4, 2007 | SESE |
| K063637 | RELIANCE VBS SYSTEM | Reliance Medical Systems, LLC | Sep 27, 2007 | SESE |
| K070754 | TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155 | Zimmer Trabecular Metal Technology | Aug 31, 2007 | SESE |
| K072132 | LDR SPINE ROI-T SYSTEM | Ldr Spine USA | Aug 30, 2007 | SESE |
| K071274 | GSO GS1 SPACER | Gold Standard Orthopedics, LLC | Aug 24, 2007 | SESE |
| K071033 | T2 XVBR SPINAL SYSTEM | Medtronic Sofamor Danek | Aug 14, 2007 | SESE |
| K071031 | VU E*POD VERTEBRAL BODY REPLACEMENT | Theken Spine, LLC | Jul 30, 2007 | SESE |
| K071497 | ATLAS SPINE VERTEBRAL BODY REPLACEMENT | Atlas Spine, Inc. | Jun 29, 2007 | SESE |
| K070786 | X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT | Theken Spine, LLC | Jun 28, 2007 | SESE |
| K063393 | SMALL STATURE SPACERS | Biomet Spine | Jun 25, 2007 | SESE |
| K071372 | MODIFICATION TO: INTERPLATE VBR SYSTEM | Rsb Spine, LLC | Jun 11, 2007 | SESE |
| K070382 | VISTA -S DEVICE | Zimmer Trabecular Metal Technology | May 30, 2007 | SESE |
| K070381 | THEKEN VU MESH VBR SYSTEM | Theken Spine, LLC | Apr 25, 2007 | SESE |
| K070082 | XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY | Vertebration,Inc | Apr 20, 2007 | SESE |
| K070316 | INTERPLATE VBR SYSTEM | Rsb Spine, LLC | Apr 19, 2007 | SESE |
| K070181 | SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX | Sintea Biotech, Inc. | Apr 18, 2007 | SESE |
| K070218 | VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR) | Vertiflex (Tm), Incorporated | Apr 6, 2007 | SESE |
| K062083 | SYNFIX -LR | Synthes Spine Co.Lp | Apr 3, 2007 | SESE |
| K070173 | VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | Mar 14, 2007 | SESE |
| K063464 | ATLAS SPINE VERTEBRAL BODY REPLACEMENT | Atlas Spine, Inc. | Mar 9, 2007 | SESE |
| K063491 | T2 SCEPTOR SPINAL SYSTEM | Medtronic Sofamor Danek | Mar 5, 2007 | SESE |
| K063205 | ATLAS SPINE VERTEBRAL BODY REPLACEMENT | Atlas Spine, LLC | Feb 26, 2007 | SESE |
| K063399 | ALEUTIAN SPACER SYSTEM | K2m, Inc. | Feb 23, 2007 | SESE |
| K062933 | SYNTHES ORACLE SPACER | Synthes Spine Co.Lp | Jan 31, 2007 | SESE |
| K062666 | VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS | Ortho Development Corp. | Jan 25, 2007 | SESE |
| K062759 | PARAMOUNT VBR SYSTEM | Innovative Spinal Technologies, Inc. | Jan 12, 2007 | SESE |
| K061578 | SSP VERTEBRAL BODY REPLACEMENT | Specialty Spine Products, LLC | Dec 26, 2006 | SESE |
| K060416 | OBELISC VERTEBRAL BODY REPLACEMENT DEVICE | Ulrich GmbH & Co. KG | Dec 26, 2006 | SESE |
| K062151 | BOX PEEK VBR SYSTEM | Innovasis, Inc. | Dec 22, 2006 | SESE |
| K061082 | MOBIS SPINAL IMPLANT | Signus Medizintechnik GmbH | Dec 18, 2006 | SESE |
| K062810 | SOLITAIRE ANTERIOR SPINAL SYSTEM | Ebi, L.P. | Oct 17, 2006 | SESE |
| K062133 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | Medtronic Spinal and Biologics Div | Sep 26, 2006 | SESE |
| K061155 | VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM | Zimmer Trabecular | Sep 22, 2006 | SESE |
| K060762 | AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM | Aesculap, Inc. | Sep 14, 2006 | SESE |
| K062427 | VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | Sep 12, 2006 | SESE |
| K061891 | SYNEX II | Synthes Spine Co.Lp | Aug 18, 2006 | SESE |
| K061401 | INTERPLATE VBR SYSTEM | Rsb Spine, LLC | Aug 18, 2006 | SESE |
| K062132 | AVS PL PEEK SPACER SYSTEM | Stryker Spine | Aug 16, 2006 | SESE |
| K062004 | MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT | Quantum Orthopedics, Inc. | Aug 15, 2006 | SESE |
| K061752 | SPINAL USA VBR SYSTEM | Spinal USA | Aug 15, 2006 | SESE |
| K062073 | VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | Aug 14, 2006 | SESE |
| K061938 | VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | Aug 9, 2006 | SESE |
| K061836 | AVS ASL PEEK SPACER SYSTEM | Stryker Spine | Aug 3, 2006 | SESE |
| K061151 | PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER) | Pioneer Surgical Technology | Jul 24, 2006 | SESE |
| K061576 | MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM | Quantum Orthopedics, Inc. | Jul 3, 2006 | SESE |
| K061380 | RETAIN RADIOLUCENT SPACER | Globus Medical, Inc. | Jun 8, 2006 | SESE |
| K061016 | EBI ESL PEEK-OPTIMA SPINE SYSTEM | Ebi, L.P. | Jun 8, 2006 | SESE |
| K060916 | ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017. | Spinal Edge, LLC | Jun 8, 2006 | SESE |
| K060506 | STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM | Stryker Spine | May 25, 2006 | SESE |
| K060665 | XPAND RADIOLUCENT CORPECTOMY SPACER | Globus Medical, Inc. | May 10, 2006 | SESE |
| K052670 | STAXX XD SYSTEM | Spine Wave, Inc. | Apr 27, 2006 | SESE |
| K060719 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | Apr 14, 2006 | SESE |
| K052641 | MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT | Quantum Orthopedics, Inc. | Apr 12, 2006 | SESE |
| K060350 | CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM | Blackstone Medical, Inc. | Feb 24, 2006 | SESE |
| K051525 | ARX SPINAL SYSTEM | Amedica Corp. | Feb 17, 2006 | SESE |
| K053508 | SYNFIX-LR | Synthes Spine Co.Lp | Feb 13, 2006 | SESE |
| K053292 | DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS | Scient'X USA, Inc. | Jan 19, 2006 | SESE |
| K052170 | SEASPINE VBR SYSTEM | Seaspine, Inc. | Dec 21, 2005 | SESE |
| K051781 | GRAFTCAGE TLX | Osteotech, Inc. | Dec 16, 2005 | SESE |
| K052210 | NUVASIVE COROENT EXTENSURE SYSTEM | Nuvasive, Inc. | Dec 12, 2005 | SESE |
| K053080 | GRAFTCAGE ACX | Osteotech, Inc. | Dec 1, 2005 | SESE |
| K052950 | THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM | Zimmer Trabecular | Nov 16, 2005 | SESE |
| K052931 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | Nov 16, 2005 | SESE |
| K051205 | STRYKER SPINE AVS ASL PEEK SPACER | Stryker Spine | Nov 4, 2005 | SESE |
| K052533 | KIMBA SPINAL IMPLANT | Signus Medizintechnik GmbH | Nov 3, 2005 | SESE |
| K052746 | CONCORDE VBR SPINAL SYSTEM | Depuy Spine, Inc. | Oct 21, 2005 | SESE |
| K052384 | LANX VBR SYSTEM | Lanx, LLC | Oct 7, 2005 | SESE |
| K052261 | MODIFICATION TO: VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | Oct 7, 2005 | SESE |
| K050997 | EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE | Flexuspine, Inc. | Oct 7, 2005 | SESE |
| K051978 | TRABECULAR METAL VERTEBRAL BODY REPLACEMENT | Implex Corp. | Sep 23, 2005 | SESE |
| K052096 | NUBIC SPINAL IMPLANT | Signus Medical, LLC | Aug 16, 2005 | SESE |
| K051454 | ALEUTIAN SPACER SYSTEM | K2m, LLC | Jul 27, 2005 | SESE |
| K051659 | SEMIAL SPINAL IMPLANT | Signus Medizintechnik GmbH | Jul 13, 2005 | SESE |
| K050449 | QUANTUM VERTEBRAL BODY REPLACEMENT | Quantum Orthopedics, Inc. | Jul 7, 2005 | SESE |
| K043479 | MC+ PARTIAL VBR | Ldr Spine USA | Jun 30, 2005 | SESE |
| K051027 | STALIF TT | Surgicraft , Ltd. | Jun 29, 2005 | SESE |
| K043349 | OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) | Ldr Spine USA | Jun 29, 2005 | SESE |
| K051196 | TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1 | Implex Corp. | Jun 17, 2005 | SESE |
| K051246 | CONSTRUX MINI PEEK VBR SYSTEM | Blackstone Medical, Inc. | Jun 14, 2005 | SESE |
| K051105 | BASIS VERTEBRAL BODY SPACER | Medtronic Sofamor Danek | Jun 9, 2005 | SESE |
| K050861 | PEEK CAS | Interpore Cross Intl. | May 27, 2005 | SESE |
| K050348 | CO VERTEBRAL BODY REPLACEMENT | Scient'X | May 27, 2005 | SESE |
| K050850 | XPAND CORPECTOMY SPACER | Globus Medical, Inc. | May 26, 2005 | SESE |
| K051000 | FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE | Spinal Concepts, Inc. | May 19, 2005 | SESE |
| K050058 | THEKEN REVEAL VBR SYSTEM | Theken Surgical,Llc | May 17, 2005 | SESE |
| K050553 | NOVEL VBR SPINAL SYSTEM | Alphatec/Nexmed | Apr 18, 2005 | SESE |
| K050624 | STRYKER SPINE AVS PL PEEK SPACER | Stryker Spine | Apr 11, 2005 | SESE |
| K042600 | STANSION MATRIX | Spineworks, LLC | Feb 18, 2005 | SESE |
| K042571 | STRYKER SPINE AVS TL PEEK SPACER | Stryker Spine | Feb 11, 2005 | SESE |
| K043405 | NUVASIVE COROENT SYSTEM | Nuvasive, Inc. | Feb 7, 2005 | SESE |
| K043316 | RABEA SPINAL IMPLANT | Signus Medizintechnik GmbH | Feb 7, 2005 | SESE |
| K041798 | ATALIA TITANIUM SURGICAL MESH | Us Spinal Technologies, LLC | Feb 7, 2005 | SESE |
| K043206 | PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER) | Pioneer Surgical Technology | Jan 21, 2005 | SESE |
| K043566 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | Jan 7, 2005 | SESE |
| K043561 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | Dec 29, 2004 | SESE |
| K042714 | FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4 | Spine Next America Corporation | Dec 29, 2004 | SESE |
| K042713 | FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5 | Spine Next America Corporation | Dec 29, 2004 | SESE |
| K041407 | TITANIUM MESH IMPLANT | Interpore Cross Intl. | Dec 29, 2004 | SESE |
Top Applicants
- Medtronic Sofamor Danek — 24 clearances
- Globus Medical, Inc. — 11 clearances
- Spine Wave, Inc. — 10 clearances
- Interpore Cross Intl. — 10 clearances
- Stryker Spine — 8 clearances
