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 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K072537 | CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM | Creaspine Sas | 2007-12-18 | Traditional | PDF ↗ |
| K073125 | VALEO VBR | Amedica Corp. | 2007-12-05 | Special | PDF ↗ |
| K071726 | ZUMA | Seaspine, Inc. | 2007-10-23 | Traditional | PDF ↗ |
| K072029 | PHENIX VERTEBRAL BODY REPLACEMENT | New Business Development, LLC | 2007-10-15 | Traditional | PDF ↗ |
| K072465 | NIKO CORPECTOMY SPACER | Globus Medical, Inc. | 2007-10-04 | Special | PDF ↗ |
| K063637 | RELIANCE VBS SYSTEM | Reliance Medical Systems, LLC | 2007-09-27 | Traditional | PDF ↗ |
| K070754 | TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155 | Zimmer Trabecular Metal Technology | 2007-08-31 | Traditional | PDF ↗ |
| K072132 | LDR SPINE ROI-T SYSTEM | Ldr Spine USA | 2007-08-30 | Special | PDF ↗ |
| K071274 | GSO GS1 SPACER | Gold Standard Orthopedics, LLC | 2007-08-24 | Traditional | PDF ↗ |
| K071033 | T2 XVBR SPINAL SYSTEM | Medtronic Sofamor Danek | 2007-08-14 | Traditional | PDF ↗ |
| K071031 | VU E*POD VERTEBRAL BODY REPLACEMENT | Theken Spine, LLC | 2007-07-30 | Traditional | PDF ↗ |
| K071497 | ATLAS SPINE VERTEBRAL BODY REPLACEMENT | Atlas Spine, Inc. | 2007-06-29 | Special | PDF ↗ |
| K070786 | X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT | Theken Spine, LLC | 2007-06-28 | Traditional | PDF ↗ |
| K063393 | SMALL STATURE SPACERS | Biomet Spine | 2007-06-25 | Traditional | PDF ↗ |
| K071372 | MODIFICATION TO: INTERPLATE VBR SYSTEM | Rsb Spine, LLC | 2007-06-11 | Special | PDF ↗ |
| K070382 | VISTA -S DEVICE | Zimmer Trabecular Metal Technology | 2007-05-30 | Traditional | PDF ↗ |
| K070381 | THEKEN VU MESH VBR SYSTEM | Theken Spine, LLC | 2007-04-25 | Traditional | PDF ↗ |
| K070082 | XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY | Vertebration,Inc | 2007-04-20 | Traditional | PDF ↗ |
| K070316 | INTERPLATE VBR SYSTEM | Rsb Spine, LLC | 2007-04-19 | Traditional | PDF ↗ |
| K070181 | SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX | Sintea Biotech, Inc. | 2007-04-18 | Traditional | PDF ↗ |
| K070218 | VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR) | Vertiflex (Tm), Incorporated | 2007-04-06 | Traditional | PDF ↗ |
| K062083 | SYNFIX -LR | Synthes Spine Co.Lp | 2007-04-03 | Traditional | PDF ↗ |
| K070173 | VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2007-03-14 | Special | PDF ↗ |
| K063464 | ATLAS SPINE VERTEBRAL BODY REPLACEMENT | Atlas Spine, Inc. | 2007-03-09 | Traditional | PDF ↗ |
| K063491 | T2 SCEPTOR SPINAL SYSTEM | Medtronic Sofamor Danek | 2007-03-05 | Traditional | PDF ↗ |
| K063205 | ATLAS SPINE VERTEBRAL BODY REPLACEMENT | Atlas Spine, LLC | 2007-02-26 | Traditional | PDF ↗ |
| K063399 | ALEUTIAN SPACER SYSTEM | K2m, Inc. | 2007-02-23 | Special | PDF ↗ |
| K062933 | SYNTHES ORACLE SPACER | Synthes Spine Co.Lp | 2007-01-31 | Traditional | PDF ↗ |
| K062666 | VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS | Ortho Development Corp. | 2007-01-25 | Traditional | PDF ↗ |
| K062759 | PARAMOUNT VBR SYSTEM | Innovative Spinal Technologies, Inc. | 2007-01-12 | Traditional | PDF ↗ |
| K060416 | OBELISC VERTEBRAL BODY REPLACEMENT DEVICE | Ulrich GmbH & Co. KG | 2006-12-26 | Traditional | PDF ↗ |
| K061578 | SSP VERTEBRAL BODY REPLACEMENT | Specialty Spine Products, LLC | 2006-12-26 | Traditional | PDF ↗ |
| K062151 | BOX PEEK VBR SYSTEM | Innovasis, Inc. | 2006-12-22 | Traditional | PDF ↗ |
| K061082 | MOBIS SPINAL IMPLANT | Signus Medizintechnik GmbH | 2006-12-18 | Special | PDF ↗ |
| K062810 | SOLITAIRE ANTERIOR SPINAL SYSTEM | Ebi, L.P. | 2006-10-17 | Special | PDF ↗ |
| K062133 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | Medtronic Spinal and Biologics Div | 2006-09-26 | Special | PDF ↗ |
| K061155 | VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM | Zimmer Trabecular | 2006-09-22 | Traditional | PDF ↗ |
| K060762 | AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM | Aesculap, Inc. | 2006-09-14 | Traditional | PDF ↗ |
| K062427 | VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | 2006-09-12 | Traditional | PDF ↗ |
| K061891 | SYNEX II | Synthes Spine Co.Lp | 2006-08-18 | Traditional | PDF ↗ |
| K061401 | INTERPLATE VBR SYSTEM | Rsb Spine, LLC | 2006-08-18 | Traditional | PDF ↗ |
| K062132 | AVS PL PEEK SPACER SYSTEM | Stryker Spine | 2006-08-16 | Special | PDF ↗ |
| K062004 | MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT | Quantum Orthopedics, Inc. | 2006-08-15 | Special | PDF ↗ |
| K061752 | SPINAL USA VBR SYSTEM | Spinal USA | 2006-08-15 | Traditional | PDF ↗ |
| K062073 | VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | 2006-08-14 | Special | PDF ↗ |
| K061938 | VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2006-08-09 | Special | PDF ↗ |
| K061836 | AVS ASL PEEK SPACER SYSTEM | Stryker Spine | 2006-08-03 | Special | PDF ↗ |
| K061151 | PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER) | Pioneer Surgical Technology | 2006-07-24 | Traditional | PDF ↗ |
| K061576 | MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM | Quantum Orthopedics, Inc. | 2006-07-03 | Special | PDF ↗ |
| K060916 | ATLAS SPINAL CAGE, MODELS SC-150-007, 009, 011, 013, 015, 017. | Spinal Edge, LLC | 2006-06-08 | Traditional | PDF ↗ |
| K061016 | EBI ESL PEEK-OPTIMA SPINE SYSTEM | Ebi, L.P. | 2006-06-08 | Special | PDF ↗ |
| K061380 | RETAIN RADIOLUCENT SPACER | Globus Medical, Inc. | 2006-06-08 | Special | PDF ↗ |
| K060506 | STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM | Stryker Spine | 2006-05-25 | Traditional | PDF ↗ |
| K060665 | XPAND RADIOLUCENT CORPECTOMY SPACER | Globus Medical, Inc. | 2006-05-10 | Special | PDF ↗ |
| K052670 | STAXX XD SYSTEM | Spine Wave, Inc. | 2006-04-27 | Traditional | PDF ↗ |
| K060719 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | 2006-04-14 | Special | PDF ↗ |
| K052641 | MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT | Quantum Orthopedics, Inc. | 2006-04-12 | Special | PDF ↗ |
| K060350 | CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM | Blackstone Medical, Inc. | 2006-02-24 | Special | PDF ↗ |
| K051525 | ARX SPINAL SYSTEM | Amedica Corp. | 2006-02-17 | Traditional | PDF ↗ |
| K053508 | SYNFIX-LR | Synthes Spine Co.Lp | 2006-02-13 | Traditional | PDF ↗ |
| K053292 | DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS | Scient'X USA, Inc. | 2006-01-19 | Special | PDF ↗ |
| K052170 | SEASPINE VBR SYSTEM | Seaspine, Inc. | 2005-12-21 | Traditional | PDF ↗ |
| K051781 | GRAFTCAGE TLX | Osteotech, Inc. | 2005-12-16 | Traditional | PDF ↗ |
| K052210 | NUVASIVE COROENT EXTENSURE SYSTEM | Nuvasive, Inc. | 2005-12-12 | Special | PDF ↗ |
| K053080 | GRAFTCAGE ACX | Osteotech, Inc. | 2005-12-01 | Traditional | PDF ↗ |
| K052950 | THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM | Zimmer Trabecular | 2005-11-16 | Special | PDF ↗ |
| K052931 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | 2005-11-16 | Special | PDF ↗ |
| K051205 | STRYKER SPINE AVS ASL PEEK SPACER | Stryker Spine | 2005-11-04 | Traditional | PDF ↗ |
| K052533 | KIMBA SPINAL IMPLANT | Signus Medizintechnik GmbH | 2005-11-03 | Traditional | PDF ↗ |
| K052746 | CONCORDE VBR SPINAL SYSTEM | Depuy Spine, Inc. | 2005-10-21 | Special | PDF ↗ |
| K052261 | MODIFICATION TO: VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2005-10-07 | Special | PDF ↗ |
| K050997 | EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE | Flexuspine, Inc. | 2005-10-07 | Traditional | PDF ↗ |
| K052384 | LANX VBR SYSTEM | Lanx, LLC | 2005-10-07 | Traditional | PDF ↗ |
| K051978 | TRABECULAR METAL VERTEBRAL BODY REPLACEMENT | Implex Corp. | 2005-09-23 | Special | PDF ↗ |
| K052096 | NUBIC SPINAL IMPLANT | Signus Medical, LLC | 2005-08-16 | Special | PDF ↗ |
| K051454 | ALEUTIAN SPACER SYSTEM | K2m, LLC | 2005-07-27 | Traditional | PDF ↗ |
| K051659 | SEMIAL SPINAL IMPLANT | Signus Medizintechnik GmbH | 2005-07-13 | Special | PDF ↗ |
| K050449 | QUANTUM VERTEBRAL BODY REPLACEMENT | Quantum Orthopedics, Inc. | 2005-07-07 | Traditional | PDF ↗ |
| K043479 | MC+ PARTIAL VBR | Ldr Spine USA | 2005-06-30 | Traditional | PDF ↗ |
| K051027 | STALIF TT | Surgicraft , Ltd. | 2005-06-29 | Traditional | PDF ↗ |
| K043349 | OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) | Ldr Spine USA | 2005-06-29 | Traditional | PDF ↗ |
| K051196 | TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1 | Implex Corp. | 2005-06-17 | Special | PDF ↗ |
| K051246 | CONSTRUX MINI PEEK VBR SYSTEM | Blackstone Medical, Inc. | 2005-06-14 | Traditional | PDF ↗ |
| K051105 | BASIS VERTEBRAL BODY SPACER | Medtronic Sofamor Danek | 2005-06-09 | Traditional | PDF ↗ |
| K050861 | PEEK CAS | Interpore Cross Intl. | 2005-05-27 | Special | PDF ↗ |
| K050348 | CO VERTEBRAL BODY REPLACEMENT | Scient'X | 2005-05-27 | Special | PDF ↗ |
| K050850 | XPAND CORPECTOMY SPACER | Globus Medical, Inc. | 2005-05-26 | Special | PDF ↗ |
| K051000 | FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE | Spinal Concepts, Inc. | 2005-05-19 | Special | PDF ↗ |
| K050058 | THEKEN REVEAL VBR SYSTEM | Theken Surgical,Llc | 2005-05-17 | Traditional | PDF ↗ |
| K050553 | NOVEL VBR SPINAL SYSTEM | Alphatec/Nexmed | 2005-04-18 | Special | PDF ↗ |
| K050624 | STRYKER SPINE AVS PL PEEK SPACER | Stryker Spine | 2005-04-11 | Traditional | PDF ↗ |
| K042600 | STANSION MATRIX | Spineworks, LLC | 2005-02-18 | Traditional | PDF ↗ |
| K042571 | STRYKER SPINE AVS TL PEEK SPACER | Stryker Spine | 2005-02-11 | Traditional | PDF ↗ |
| K041798 | ATALIA TITANIUM SURGICAL MESH | Us Spinal Technologies, LLC | 2005-02-07 | Traditional | PDF ↗ |
| K043316 | RABEA SPINAL IMPLANT | Signus Medizintechnik GmbH | 2005-02-07 | Traditional | PDF ↗ |
| K043405 | NUVASIVE COROENT SYSTEM | Nuvasive, Inc. | 2005-02-07 | Traditional | PDF ↗ |
| K043206 | PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER) | Pioneer Surgical Technology | 2005-01-21 | Traditional | PDF ↗ |
| K043566 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | 2005-01-07 | Special | PDF ↗ |
| K043561 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM | Medtronic Sofamor Danek | 2004-12-29 | Special | PDF ↗ |
| K042714 | FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4 | Spine Next America Corporation | 2004-12-29 | Traditional | PDF ↗ |
Product code MQP · Class II · Orthopedic. Data: openFDA.