FDA Product Code
FDA Product Code MAX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3080
510(k) Clearances — 896 records · page 9 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K101301 | STALIF MIDLINE | Centinel Spine | 2010-09-24 | Special | PDF ↗ |
| K100037 | ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD | Advanced Vertebral Solutions, LLC | 2010-09-23 | Traditional | PDF ↗ |
| K100210 | TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T | Trans1 Incorporated | 2010-08-26 | Traditional | PDF ↗ |
| K101051 | AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX | Stryker Spine | 2010-08-12 | Traditional | PDF ↗ |
| K100865 | AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX | Stryker Spine | 2010-08-11 | Traditional | PDF ↗ |
| K100743 | ATLAS SPINE PIVOTING SYSTEM | Atlas Spine, Inc. | 2010-08-10 | Traditional | PDF ↗ |
| K100820 | WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM | Wenzel Spine | 2010-08-05 | Traditional | PDF ↗ |
| K100544 | IMPIX LUMBAR INTERBODY DEVICE | Medicrea Technologies | 2010-07-22 | Special | PDF ↗ |
| K101720 | JULIET OL | Spineart | 2010-07-16 | Special | PDF ↗ |
| K101085 | SPINESMITH CYNCH SPINAL SYSTEM | Spine Smith Partners L.P. | 2010-07-01 | Special | PDF ↗ |
| K092815 | S-LIF INTERVERTEBRAL BODY FUSION DEVICE | Spinefrontier, Inc. | 2010-06-30 | Abbreviated | PDF ↗ |
| K100175 | CLYDESDALE SPINAL SYSTEM | Medtronic Sofamor Danek | 2010-06-02 | Traditional | PDF ↗ |
| K083798 | IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF | Medicrea Technologies | 2010-05-19 | Traditional | PDF ↗ |
| K100089 | SYNTHES T-PAL SPACER | Synthes Spine | 2010-05-13 | Traditional | PDF ↗ |
| K092901 | EPICAGE INTERBODY FUSION DEVICE | R Tree Innovations | 2010-04-28 | Traditional | PDF ↗ |
| K094025 | CRESCENT SPINAL SYSTEM | Medtronic Sofamor Danek | 2010-04-26 | Traditional | PDF ↗ |
| K093669 | SEC IBF CAGE | Innvotec Surgical, Inc. | 2010-03-18 | Traditional | PDF ↗ |
| K093864 | AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX | Stryker Corp. | 2010-03-11 | Special | PDF ↗ |
| K093015 | BINDER INTERVERTEBRAL BODY FUSION DEVICE | Binder Biomedical, Inc. | 2010-02-25 | Traditional | PDF ↗ |
| K092574 | ESL SPINAL SYSTEM | Ebi, L.P. | 2010-02-04 | Traditional | PDF ↗ |
| K092774 | ATLAS INTERVERTEBRAL BODY CAGE | Spinal Edge, LLC | 2010-02-02 | Traditional | PDF ↗ |
| K091278 | VALEO SPACER SYSTEM | Amedica Corp. | 2010-01-28 | Traditional | PDF ↗ |
| K092162 | 4CIS PEEK, PLIF AND TLIF CAGE SYSTEM | Solco Biomedical Co., Ltd. | 2010-01-06 | Traditional | PDF ↗ |
| K093242 | PATRIOT TRANSCONTINENTAL LLIF SPACER | Globus Medical, Inc. | 2009-12-23 | Special | PDF ↗ |
| K093704 | AVS PL PEEK SPACERS | Stryker Corp. | 2009-12-23 | Special | PDF ↗ |
| K093675 | INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076 | Vertebral Technologies, Inc. | 2009-12-23 | Special | PDF ↗ |
| K092017 | PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD) | Captiva Spine, Inc. | 2009-12-01 | Traditional | PDF ↗ |
| K083626 | DISTRACTABLE WAVE CAGE | Advanced Medical Technology, Inc. | 2009-10-19 | Special | PDF ↗ |
| K090353 | PERIMETER INTERBODY FUSION DEVICE | Medtronic Sofamor Danek | 2009-09-29 | Traditional | PDF ↗ |
| K092193 | SPINAL USA INTERBODY CAGES | Spinal USA | 2009-09-25 | Traditional | PDF ↗ |
| K091122 | DIANA FUSION CAGE | Signus Medical | 2009-09-18 | Traditional | PDF ↗ |
| K091638 | DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031 | Spinefrontier, Inc. | 2009-09-14 | Abbreviated | PDF ↗ |
| K090048 | ASFORA BULLET CAGE SYSTEM | Medical Designs, LLC | 2009-08-14 | Traditional | PDF ↗ |
| K091381 | IBEX SPINAL SYSTEM | Ebi, L.P. | 2009-08-07 | Traditional | PDF ↗ |
| K091988 | MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076 | Vertebral Technologies, Inc. | 2009-07-30 | Special | PDF ↗ |
| K090707 | TALOS INTERVERTEBRAL BODY FUSION DEVICE | Meditech Advisors, LLC | 2009-07-15 | Traditional | PDF ↗ |
| K090507 | MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM | Ldr Spine USA | 2009-06-25 | Special | PDF ↗ |
| K090566 | PATHWAY AVID | Custom Spine, Inc. | 2009-06-01 | Traditional | PDF ↗ |
| K081917 | DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS | Depuy Spine, Inc. | 2009-05-22 | Traditional | PDF ↗ |
| K090425 | GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM | Alphatec Spine, Inc. | 2009-05-19 | Traditional | PDF ↗ |
| K090899 | DEPUY SPINE LATERAL SYSTEM | Depuy Spine, Inc. | 2009-05-19 | Traditional | PDF ↗ |
| K090816 | STRYKER SPINE AVS PL PEEK SPACERS | Stryker Corp. | 2009-04-24 | Special | PDF ↗ |
| K090782 | NOVEL ALIF SPINAL SPACER SYSTEM | Alphatec Spine, Inc. | 2009-04-22 | Special | PDF ↗ |
| K090166 | AVS ANTERIOR LARGE PEEK SPACERS | Stryker Corp. | 2009-04-22 | Traditional | PDF ↗ |
| K082698 | ALEUTIAN IBF SYSTEM | K2m, Inc. | 2009-04-21 | Traditional | PDF ↗ |
| K083815 | LANX FUSION SYSTEM | Lanx, Inc. | 2009-04-20 | Traditional | PDF ↗ |
| K083714 | ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD) | Titan Spine, LLC | 2009-04-15 | Traditional | PDF ↗ |
| K090064 | EMINENT SPINE INTERBODY FUSION SYSTEM | Eminent Spine | 2009-04-09 | Traditional | PDF ↗ |
| K090376 | SPINESMITH CYNCH SPINAL SYSTEM | Spine Smith Partners L.P. | 2009-04-01 | Traditional | PDF ↗ |
| K083661 | AVS TL PEEK SPACERS | Stryker Corp. | 2009-02-27 | Traditional | PDF ↗ |
| K081888 | DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE | Spineart | 2009-02-06 | Traditional | PDF ↗ |
| K082262 | LDR SPINE ROI INTERBODY FUSION SYSTEM | Ldr Spine USA | 2009-02-02 | Traditional | PDF ↗ |
| K082406 | EXPANDABLE PEEK-OPTIMA IMPLANT | Ebi, L.P. | 2009-01-14 | Traditional | PDF ↗ |
| K082712 | THEKEN SPINE VU EPOD AND VU LPOD SYSTEM | Theken Spine, LLC | 2009-01-02 | Traditional | PDF ↗ |
| K083026 | CLYDESDALE SPINAL SYSTEM | Medtronic Sofamor Danek | 2008-12-29 | Traditional | PDF ↗ |
| K082128 | DEPUY SPINE LATERAL CAGE SYSTEM | Depuy Spine | 2008-11-14 | Traditional | PDF ↗ |
| K081673 | DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE | Ionics Medical Corp. | 2008-11-14 | Abbreviated | PDF ↗ |
| K082310 | HOLLYWOOD, PACIFICA, REDONDO, VENTURA | Seaspine, Inc. | 2008-11-10 | Traditional | PDF ↗ |
| K082774 | LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE | Lanx, LLC | 2008-10-21 | Traditional | PDF ↗ |
| K082260 | INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES | Calvary Spine, LLC | 2008-10-17 | Traditional | PDF ↗ |
| K082732 | MODIFICATION TO: CAPSTONE SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2008-10-16 | Special | PDF ↗ |
| K081196 | SPINAL USA VBR SYSTEM | Spinal USA | 2008-10-16 | Traditional | PDF ↗ |
| K082270 | OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM | Vertiflex, Inc. | 2008-09-16 | Special | PDF ↗ |
| K082342 | MODIFICATION TO CAPSTONE SPINAL SYSTEM | Medtronic Sofamor Danek | 2008-09-12 | Special | PDF ↗ |
| K082235 | BLACKSTONE PILLAR XL PEEK SPACERS | Blackstone Medical, Inc. | 2008-09-04 | Special | PDF ↗ |
| K081636 | PEEK-OPTIMA ALIF SPACER | Biomet Spine | 2008-08-07 | Traditional | PDF ↗ |
| K081968 | MODIFICATION TO LUCENT | Spinal Elements, Inc. | 2008-08-05 | Special | PDF ↗ |
| K082014 | STRYKER SPINE AVS PL PEEK SPACERS | Stryker Corp. | 2008-07-28 | Special | PDF ↗ |
| K081177 | BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM | Blackstone Medical, Inc. | 2008-07-23 | Traditional | PDF ↗ |
| K080537 | L-VARLOCK | Kiscomedica S.A. | 2008-06-30 | Traditional | PDF ↗ |
| K080615 | ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD) | Titan Spine, LLC | 2008-06-17 | Traditional | PDF ↗ |
| K080673 | INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE | Vertebral Technologies, Inc. | 2008-06-10 | Traditional | PDF ↗ |
| K080588 | SCIENT'X TRIBECA VBR | Scient'X USA, Inc. | 2008-05-30 | Traditional | PDF ↗ |
| K080411 | PLATEAU SPACER SYSTEM | Life Spine | 2008-05-15 | Traditional | PDF ↗ |
| K073177 | PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM | Pioneer Surgical Technology | 2008-05-13 | Abbreviated | PDF ↗ |
| K080314 | SPINAL USA INTERBODY FUSION DEVICE | Spinal USA | 2008-05-13 | Traditional | PDF ↗ |
| K080401 | SHELL CAGE, WAVE CAGE, LOOP CAGE | Advanced Medical Technologies AG | 2008-05-09 | Traditional | PDF ↗ |
| K071983 | AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE | Aesculap Implant Systems, Inc. | 2008-05-01 | Traditional | PDF ↗ |
| K080281 | PATHWAY | Custom Spine, Inc. | 2008-05-01 | Traditional | PDF ↗ |
| K073291 | CAPSTONE SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2008-04-24 | Traditional | PDF ↗ |
| K073440 | FOUNDATION CAGE | Corelink, LLC | 2008-04-24 | Traditional | PDF ↗ |
| K080058 | TURBO PRIME IBD SYSTEM | Spineselect, LLC | 2008-04-16 | Traditional | PDF ↗ |
| K080083 | INTREPID SPINAL SYSTEM | Medtronic Sofamor Danek | 2008-04-10 | Traditional | PDF ↗ |
| K080758 | AVS PL PEEK SPACERS, MODELS 48351 AND 48353 | Stryker Corp. | 2008-03-27 | Special | PDF ↗ |
| K073470 | AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX | Stryker Spine | 2008-03-06 | Traditional | PDF ↗ |
| K073669 | ORIA NATURA SPACER | Choicespine, LP | 2008-02-13 | Traditional | PDF ↗ |
| K073202 | ARDIS SPACER | Abbott Spine, Inc. | 2008-01-30 | Traditional | PDF ↗ |
| K073144 | LANX INTERVERTEBRAL BODY FUSION DEVICE | Lanx, LLC | 2008-01-24 | Traditional | PDF ↗ |
| K072970 | PATRIOT SPACERS | Globus Medical, Inc. | 2008-01-18 | Traditional | PDF ↗ |
| K073348 | LUCENT MAGNUM | Spinal Elements, Inc. | 2007-12-26 | Special | PDF ↗ |
| K072791 | ORACLE SPACER, OPAL SPACER | Synthes Spine | 2007-12-26 | Traditional | PDF ↗ |
| K072226 | IMPIX SPACER | Medicrea Technologies | 2007-12-10 | Traditional | PDF ↗ |
| K071795 | NUVASIVE COROENT SYSTEM | Nuvasive, Inc. | 2007-12-04 | Abbreviated | PDF ↗ |
| K071724 | LUCENT | Spinal Elements, Inc. | 2007-11-09 | Traditional | PDF ↗ |
| K072289 | SPINEFRONTIER DORADO VBR | Spinefrontier, Inc. | 2007-11-01 | Traditional | PDF ↗ |
| K072120 | PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE | Innovative Spinal Technologies, Inc. | 2007-10-11 | Traditional | PDF ↗ |
Product code MAX · Class II · Orthopedic. Data: openFDA.