FDA Product Code
FDA Product Code ODP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3080
510(k) Clearances — 354 records · page 4 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K113559 | LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS | Ldr Spine USA, Inc. | 2011-12-29 | Special | PDF ↗ |
| K112664 | ZAVATION IBF SYSTEMS | Zavation, LLC | 2011-12-23 | Traditional | PDF ↗ |
| K112862 | MECTA-C | Medacta International | 2011-12-19 | Traditional | PDF ↗ |
| K111123 | VARILIFT CERVICAL INTERBODY FUSION SYSTEM | Wenzel Spine | 2011-12-08 | Traditional | PDF ↗ |
| K112361 | ALAMO C | Alliance Partners, LLC | 2011-11-30 | Traditional | PDF ↗ |
| K111119 | TRABECULAR METAL (TM) FUSION DEVICE | Zimmer Spine, Inc. | 2011-11-23 | Traditional | PDF ↗ |
| K111983 | VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX | Zimmer Trabecular Metal Technology | 2011-11-18 | Traditional | PDF ↗ |
| K112444 | ANATOMIC PEEK CERVICAL FUSION SYSTEM | Medtronic Sofamor Danck USA, Inc. | 2011-11-15 | Traditional | PDF ↗ |
| K110442 | NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM | Nanovis, LLC | 2011-11-09 | Traditional | PDF ↗ |
| K112036 | CALIX PC SPINAL IMPLANT SYSTEM | X-Spine Systems, Inc. | 2011-11-08 | Traditional | PDF ↗ |
| K111264 | CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM | Medtronic Sofamor Danek USA | 2011-10-12 | Special | PDF ↗ |
| K111484 | DISCOVERY | Intuitive Spine, LLC | 2011-09-12 | Traditional | PDF ↗ |
| K110733 | DAYTONA ANTERIOR CERVICAL CAGE | Spinenet, LLC | 2011-08-25 | Traditional | PDF ↗ |
| K100967 | PERIMETER C SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2011-08-05 | Traditional | PDF ↗ |
| K111675 | VU C*POD INTERVERTEBRAL BODY FUSION DEVICE | Theken Spine, LLC | 2011-08-02 | Special | PDF ↗ |
| K110915 | CERVICAL CAGE | Eisertech, LLC | 2011-07-22 | Abbreviated | PDF ↗ |
| K111835 | PLATEAU SPACER SYSTEM | Life Spine, Inc. | 2011-07-19 | Special | PDF ↗ |
| K103655 | OCTANE-C INTERBODY FUSION DEVICE SYSTEM | Exactech, Inc. | 2011-06-30 | Traditional | PDF ↗ |
| K110585 | CAPTIVA SPINE FUSELOX CERVICAL CAGE | Captiva Spine, Inc. | 2011-03-25 | Special | PDF ↗ |
| K100698 | STCC | Cardinal Spine, LLC | 2011-03-14 | Traditional | PDF ↗ |
| K103169 | ALEUTTIAN | K2m, Inc. | 2011-03-07 | Special | PDF ↗ |
| K103660 | LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM | Lanx, Inc. | 2011-02-28 | Special | PDF ↗ |
| K102449 | BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM | Bright Spine, Inc. | 2011-02-11 | Traditional | PDF ↗ |
| K101171 | ORTHOVITA PEEK SPACER | Orthovita, Inc. | 2011-01-25 | Traditional | PDF ↗ |
| K103033 | TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX | Zimmer Trabecular Metal Technology | 2011-01-10 | Traditional | PDF ↗ |
| K101363 | VU CPOD INTERVERTEBRAL BODU FUSION DEVICE | Musculoskeletal Clinical Regulatory Advisers | 2010-12-16 | Traditional | PDF ↗ |
| K093093 | SMALL PLATEAU SPACER SYSTEM | Life Spine | 2010-10-13 | Traditional | PDF ↗ |
| K101812 | CONSTRUX MINI PEEK SPACER SYSTEM | Orthofix, Inc. | 2010-09-27 | Traditional | PDF ↗ |
| K092794 | TRANSCORP ACIF SYSTEM | Transcorp, Inc. | 2010-09-13 | Traditional | PDF ↗ |
| K100889 | ENDOSKELETON TC | Titan Spine, LLC | 2010-07-29 | Traditional | PDF ↗ |
| K101302 | ALEUTIAN IBF SYSTEM | K2m, Inc. | 2010-07-22 | Special | PDF ↗ |
| K100214 | CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE | Medtronic Sofamor Danek | 2010-06-25 | Traditional | PDF ↗ |
| K100484 | IMPIX MANTA CERVICAL INTERBODY DEVICE | Medicrea | 2010-03-16 | Special | PDF ↗ |
| K092540 | C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER | Rsb Spine, LLC | 2010-01-27 | Special | PDF ↗ |
| K092904 | PATHWAY IVB/VBR | Custom Spine, Inc. | 2009-12-22 | Traditional | PDF ↗ |
| K091531 | CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER | Choice Spine, Llp | 2009-11-02 | Traditional | PDF ↗ |
| K090887 | ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGES | SpineCraft | 2009-10-30 | Traditional | PDF ↗ |
| K091873 | TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-CA 12 05-S, MOS-CA 12 O6-S | Spineart | 2009-09-18 | Abbreviated | PDF ↗ |
| K082848 | NUBIC AND RABEA DEVICES | Signus Medizintechnik GmbH | 2009-07-24 | Traditional | PDF ↗ |
| K091088 | LDR SPINE CERVICAL INTERBODY FUSION SYSTEM | Ldr Spine USA | 2009-07-14 | Traditional | PDF ↗ |
| K083118 | SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE | Spinal USA | 2009-05-27 | Traditional | PDF ↗ |
| K083637 | CALIX SPINAL IMPLANT SYSTEM | X-Spine Systems, Inc. | 2009-04-20 | Traditional | PDF ↗ |
| K082309 | CAMBRIA | Seaspine, Inc. | 2009-04-09 | Traditional | PDF ↗ |
| K083425 | FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE | Adaptive Specialty, LLC | 2009-03-20 | Traditional | PDF ↗ |
| K083311 | AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM | Aesculap Implant Systems, Inc. | 2009-03-04 | Traditional | PDF ↗ |
| K083167 | PHENIX CERVICAL INTERBODY DEVICE | Spinal Devices, LLC | 2009-01-13 | Traditional | PDF ↗ |
| K082801 | PHANTOM PLUS CAGE SYSTEM | Us Spine | 2008-12-22 | Traditional | PDF ↗ |
| K081880 | ATLAS SPINE SPACER | Atlas Spine, Inc. | 2008-10-02 | Traditional | PDF ↗ |
| K081611 | NUVASIVE COROENT SYSTEM | Nuvasive, Inc. | 2008-10-02 | Traditional | PDF ↗ |
| K081730 | NOVEL CERVICAL SPINAL SPACER SYSTEM | Alphatec Spine, Inc. | 2008-09-19 | Traditional | PDF ↗ |
| K081614 | ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES | Interbody Innovations, Llp | 2008-09-05 | Traditional | PDF ↗ |
| K073320 | CIMPLICITY SPINAL SYSTEM | Spine Smith Partners L.P. | 2008-02-07 | Traditional | PDF ↗ |
| K073351 | CRYSTAL | Spinal Elements, Inc. | 2008-01-24 | Traditional | PDF ↗ |
| K072991 | PATRIOT SPACERS: COLONIAL ACDF | Globus Medical, Inc. | 2008-01-18 | Traditional | PDF ↗ |
Product code ODP · Class II · Orthopedic. Data: openFDA.