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 8 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K122956 | FUSELOX LUMBAR INTERBODY FUSION DEVICE | Captiva Spine | 2012-10-25 | Special | PDF ↗ |
| K122989 | BIOMET LATERAL SPACER SYSTEM | Biomet Spine (Aka Ebi, LLC) | 2012-10-24 | Traditional | PDF ↗ |
| K122896 | COUGAR LS 15 LATERAL CAGE SYSTEM | Medos International SARL | 2012-10-18 | Special | PDF ↗ |
| K121581 | BOX PEEK VBR SYSTEM, | Innovasis, Inc. | 2012-10-17 | Traditional | PDF ↗ |
| K120401 | ALAMO T | Alliance Partners, LLC | 2012-10-05 | Traditional | PDF ↗ |
| K121567 | ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM | Accel Spine | 2012-09-26 | Traditional | PDF ↗ |
| K122021 | STERISPINE LC CAGE | Safe Orthopaedics | 2012-09-20 | Abbreviated | PDF ↗ |
| K122591 | CLYDESDALE SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2012-09-18 | Special | PDF ↗ |
| K122047 | ALAMO P | Alliance Partners, LLC | 2012-09-04 | Traditional | PDF ↗ |
| K122317 | TETRIS II | Signus Medizintechnik GmbH | 2012-08-29 | Special | PDF ↗ |
| K121760 | CAPSTONE SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2012-08-29 | Traditional | PDF ↗ |
| K121892 | PHANTOM PLUS CERAMIC CAGE SYSTEM | Amedica Corp. | 2012-08-24 | Special | PDF ↗ |
| K120991 | TRANS1 INTERBODY FUSION SYSTEM | Trans1 Incorporated | 2012-08-23 | Traditional | PDF ↗ |
| K121733 | INFILL INTERVERTEBRAL BODY FUSION DEVICE | Pinnacle Spine Group, LLC | 2012-07-13 | Special | PDF ↗ |
| K121096 | VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM | L&K BIOMED Co., Ltd. | 2012-07-06 | Special | PDF ↗ |
| K121683 | ACCULIF TL CAGE | Coalign Innovations, Inc. | 2012-07-05 | Special | PDF ↗ |
| K120966 | DEPUY PULSE LUMBAR CAGE SYSTEM | Medos International SARL | 2012-07-03 | Traditional | PDF ↗ |
| K121288 | FUSE CAGE | Advanced Medical Technologies AG | 2012-06-29 | Traditional | PDF ↗ |
| K121333 | WAVE D CAGE | Advanced Medical Technologies AG | 2012-06-29 | Traditional | PDF ↗ |
| K121330 | WAVE O CAGE | Advanced Medical Technologies AG | 2012-06-29 | Traditional | PDF ↗ |
| K121332 | LOOP CAGE | Advanced Medical Technologies AG | 2012-06-29 | Traditional | PDF ↗ |
| K120918 | NUVASIVE COROENT TITANIUM SYSTEM | Nuvasive, Inc. | 2012-06-28 | Traditional | PDF ↗ |
| K120203 | TM-400 DEVICE | Zimmer Trabecular Metal Technology, Inc. | 2012-06-15 | Traditional | PDF ↗ |
| K121246 | MEDYSSY LT CAGE SYSTEM | Medyssey Co, Ltd. | 2012-06-15 | Special | PDF ↗ |
| K121129 | SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE | Spineology, Inc. | 2012-06-13 | Special | PDF ↗ |
| K113561 | TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION | Zimmer Trabecular Metal Technology | 2012-05-29 | Traditional | PDF ↗ |
| K110632 | LUCENT OR LUCENT MAGNUM | Spinal Elements, Inc. | 2012-05-23 | Traditional | PDF ↗ |
| K121116 | PLATEAU SPACER SYSTEM | Life Spine | 2012-05-08 | Special | PDF ↗ |
| K112986 | LATERAL FUSION DEVICE | Integra Spine (Integra Lifesciences) | 2012-05-01 | Special | PDF ↗ |
| K120063 | VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM | L&K BIOMED Co., Ltd. | 2012-04-19 | Special | PDF ↗ |
| K112696 | TWIN PEAKS LUMBAR CAGE | Qualgenix, LLC | 2012-04-18 | Traditional | PDF ↗ |
| K120368 | CAPSTONE CONTROL SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2012-04-09 | Traditional | PDF ↗ |
| K120576 | ZAVATION IBF SYSTEM | Zavation, LLC | 2012-03-28 | Special | PDF ↗ |
| K112648 | ASFORA BULLET CAGE | Medical Designs, LLC | 2012-03-13 | Special | PDF ↗ |
| K113540 | RELIANCE LUMBAR IBF SYSTEM | Reliance Medical Systems, LLC | 2012-03-12 | Traditional | PDF ↗ |
| K111792 | MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI | Signus Medizintechnik GmbH | 2012-03-05 | Traditional | PDF ↗ |
| K113478 | PLIF CAGE | Eisertech, LLC | 2012-03-05 | Abbreviated | PDF ↗ |
| K120293 | SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE | Spineology, Inc. | 2012-02-29 | Special | PDF ↗ |
| K120024 | MECTALIF TRANSFORAMINAL | Medacta International S.A. | 2012-02-28 | Special | PDF ↗ |
| K111726 | PATHWAY AVID | Custom Spine, Inc. | 2012-02-06 | Traditional | PDF ↗ |
| K113642 | PERIMETER INTERBODY FUSION DEVICE | Medtronic Sofamor Danek USA | 2012-02-06 | Traditional | PDF ↗ |
| K113447 | RISE SPACER | Globus Medical, Inc. | 2012-01-26 | Special | PDF ↗ |
| K113030 | SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE | Spineology, Inc. | 2012-01-26 | Special | PDF ↗ |
| K113527 | OPTICAGE INTERBODY FUSION DEVICE | Interventional Spine, Inc. | 2012-01-20 | Traditional | PDF ↗ |
| K113138 | ALEUTIAN SYSTEM | K2m, Inc. | 2012-01-10 | Special | PDF ↗ |
| K113528 | CLYDESDALE(R) SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2011-12-20 | Special | PDF ↗ |
| K112316 | 4-WEB ALIF SPINAL TRUSS SYSTEM (STS) | 4-Web, Inc. | 2011-12-14 | Special | PDF ↗ |
| K113348 | COUGAR SYSTEM | Johnson & Johnson | 2011-12-13 | Special | PDF ↗ |
| K113465 | ACCULIF TL CAGE | Coalign Innovations, Inc. | 2011-12-12 | Special | PDF ↗ |
| K112095 | ACCULIF TL-PEEK IBF CAGE | Coalign Innovations, Inc. | 2011-12-01 | Traditional | PDF ↗ |
| K112405 | CLYDESDALES SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2011-11-21 | Traditional | PDF ↗ |
| K110562 | TELAMON PEEK SPINAL SYSTEM | Medtronic Sofamor Danek USA | 2011-11-09 | Traditional | PDF ↗ |
| K112359 | PROW FUSION | Nlt Spine, Ltd. | 2011-11-08 | Traditional | PDF ↗ |
| K111512 | BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM | Thompson Mis, Inc. | 2011-10-26 | Traditional | PDF ↗ |
| K111965 | VUSION(R) OS | Ortho Development | 2011-10-25 | Traditional | PDF ↗ |
| K110783 | VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE | L&K BIOMED Co., Ltd. | 2011-10-24 | Traditional | PDF ↗ |
| K112014 | ZYSTON STRAIGHT SPACER SYSTEM | Biomet Spine | 2011-10-17 | Traditional | PDF ↗ |
| K111354 | GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF) | GS Medical Co., Ltd. | 2011-10-17 | Special | PDF ↗ |
| K110694 | CONCORDE BULLET SPINAL SYSTEM | Johnson & Johnson | 2011-10-11 | Special | PDF ↗ |
| K112496 | PIONEER CROSSFUSE II IBF/VBR SYSTEM | Pioneer Surgical Technology, Inc. | 2011-09-28 | Special | PDF ↗ |
| K111553 | SPINEFRONTIER LUMBAR IBF SYSTEM | Spinefrontier, Inc. | 2011-09-28 | Abbreviated | PDF ↗ |
| K111880 | SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE | Spineology, Inc. | 2011-09-26 | Traditional | PDF ↗ |
| K110659 | MEDICAL CONCEPTS INTERBODY FUSION SYSTEM | Medical Concepts, Inc. | 2011-09-13 | Traditional | PDF ↗ |
| K111166 | A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.) | Spineworks, LLC | 2011-09-08 | Traditional | PDF ↗ |
| K111525 | PERIMETER INTERBODY FUSION DEVICE | Medtronic Sofamor Danek | 2011-08-24 | Special | PDF ↗ |
| K110543 | CRESCENT (R) SPINAL SYSTEM TITANIUM | Medtronic Sofamor Danek USA, Inc. | 2011-08-09 | Special | PDF ↗ |
| K100305 | ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER | Icotec | 2011-07-21 | Traditional | PDF ↗ |
| K111774 | PATHWAY MODEL 07XXXX | Custom Spine | 2011-07-20 | Special | PDF ↗ |
| K103731 | CAPSTONE R SPINAL SYSTEM | Medtronic Sofamor Danek | 2011-07-18 | Traditional | PDF ↗ |
| K111569 | PLATEAU SPACER SYSTEM | Life Spine | 2011-07-06 | Special | PDF ↗ |
| K110650 | ZYSTON ARC INTERBODY SPACER | Biomet Spine (Aka Ebi, LLC) | 2011-06-30 | Traditional | PDF ↗ |
| K110843 | ALEUTIAN SPACER SYSTEM | K2m, Inc. | 2011-06-22 | Special | PDF ↗ |
| K110927 | MECTALIF | Medacta International | 2011-06-13 | Traditional | PDF ↗ |
| K110933 | SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE | Spineology, Inc. | 2011-06-13 | Traditional | PDF ↗ |
| K110226 | INTERFUSE T INVERTEBRAL BODY FUSION DEVICE | Vertebral Technologies, Inc. | 2011-05-27 | Special | PDF ↗ |
| K110454 | COUGAR LS LATERAL CAGE SYSTEM | Johnson & Johnson | 2011-05-13 | Special | PDF ↗ |
| K102026 | SEASPINE SPACER SYSTEM | Seaspine, Inc. | 2011-05-12 | Traditional | PDF ↗ |
| K102957 | CUTTING EDGE SPINE INTERBODY FUSION DEVICE | Cutting Edge Spine, LLC | 2011-04-28 | Traditional | PDF ↗ |
| K110177 | HELENA SYSTEM | Royal Oak Medical Devices | 2011-04-21 | Traditional | PDF ↗ |
| K103729 | INFILL INTERVERTEBRAL BODY FUSION DEVICE | Pinnacle Spine Group, LLC | 2011-04-18 | Traditional | PDF ↗ |
| K110067 | LP CAGE | Medyssey Co, Ltd. | 2011-04-08 | Traditional | PDF ↗ |
| K110270 | ACCULIF CAGE | Coalign Innovations, Inc. | 2011-04-07 | Special | PDF ↗ |
| K103666 | LANX LATERAL | Lanx, Inc. | 2011-03-23 | Traditional | PDF ↗ |
| K103111 | FORZA SPACER SYSTEM | Orthofix, Inc. | 2011-03-23 | Traditional | PDF ↗ |
| K103814 | PEZO INTERBODY CAGES SYSTEM | Ulrich GmbH & Co. KG | 2011-03-17 | Traditional | PDF ↗ |
| K103743 | CONCORDE CURVE SYSTEM | Johnson & Johnson | 2011-03-17 | Special | PDF ↗ |
| K103488 | CONCORDE BULLET CAGE SYSTEM | Johnson and Johnson | 2011-03-02 | Special | PDF ↗ |
| K100945 | FUSE PLIF CAFE | Advanced Medical Technologies AG | 2011-02-09 | Traditional | PDF ↗ |
| K110045 | INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE | Vertebral Technologies, Inc. | 2011-02-03 | Special | PDF ↗ |
| K103297 | REDONDO-L | Seaspine, Inc. | 2011-01-27 | Special | PDF ↗ |
| K083894 | ALIF SPINAL TRUSS INTERBODY FUSION DEVICE | 4-Web Spine, LLC | 2011-01-18 | Traditional | PDF ↗ |
| K102322 | STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF) | Omni Surgical, L.P. | 2011-01-07 | Traditional | PDF ↗ |
| K102293 | CALIBER SPACER | Globus Medical, Inc. | 2011-01-05 | Traditional | PDF ↗ |
| K103228 | PARAMOUNT R IBF DEVICE | Theken Spine, LLC | 2011-01-05 | Special | PDF ↗ |
| K103034 | GENESYS SPINE INTERBODY FUSION SYSTEM | Genesys Spine | 2010-12-10 | Traditional | PDF ↗ |
| K102313 | PATRIOT TRANSCONTINENTAL M SPACERS | Globus Medical, Inc. | 2010-12-03 | Traditional | PDF ↗ |
| K101923 | CONCORDE CURVE SYSTEM | Depuy Spine | 2010-12-01 | Special | PDF ↗ |
| K102067 | ENDOSKELETON TO | Titan Spine, LLC | 2010-11-05 | Traditional | PDF ↗ |
| K102277 | INTERFUSE T INVERTEBRAL BODY FUSION DEVICE | Vertebral Technologies, Inc. | 2010-10-06 | Special | PDF ↗ |
| K100042 | DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM | Difusion Technologies | 2010-10-01 | Traditional | PDF ↗ |
Product code MAX · Class II · Orthopedic. Data: openFDA.