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 7 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K140770 | MLX - MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM | Nu Vasive, Incorporated | 2014-07-25 | Traditional | PDF ↗ |
| K132907 | PLIF LITE AND TLIF LITE | Sintea Plustek | 2014-07-24 | Traditional | PDF ↗ |
| K141217 | ACCULIF TL AND PL CAGE | Stryker Corporation | 2014-07-16 | Special | PDF ↗ |
| K140142 | CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON) | Choicespine, LP | 2014-07-16 | Traditional | PDF ↗ |
| K133053 | MILESTONE SPINAL SYSTEM | Weigao Orthopaedic Device Co., Ltd. | 2014-07-15 | Traditional | PDF ↗ |
| K133813 | FLXFIT INTERVERTEBRAL BODY FUSION DEVICE | Expanding Orthopedics, Inc. | 2014-07-15 | Traditional | PDF ↗ |
| K140162 | AP EXPANDABLE XLIF SYSTEM | Nuvasive, Inc. | 2014-07-02 | Traditional | PDF ↗ |
| K140055 | ENDOSKELETON(R) TL INTERBODY FUSION DEVICE | Titan Spine, LLC | 2014-07-02 | Traditional | PDF ↗ |
| K140411 | ALTERA SPACER | Globus Medical, Inc. | 2014-07-01 | Traditional | PDF ↗ |
| K140659 | COROENT THORACOLUMBAR IMPLANTS | Nu Vasive, Incorporated | 2014-06-26 | Traditional | PDF ↗ |
| K140759 | BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL | Medos International SARL | 2014-06-13 | Special | PDF ↗ |
| K140564 | BN LUMBAR CAGE SYSTEM | Medyssey USA, Inc. | 2014-06-05 | Traditional | PDF ↗ |
| K132852 | PEEK CAGE FOR THE VERTEBRAL SPINE | Neoortho Produtos Ortopedicos S/A | 2014-05-29 | Traditional | PDF ↗ |
| K140709 | SKYHAWK INTERBODY FUSION SYSTEM | Orthofix, Inc. | 2014-05-27 | Traditional | PDF ↗ |
| K133418 | INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM | Seaspine, Inc. | 2014-05-01 | Traditional | PDF ↗ |
| K133514 | XCAGE INTERBODY FUSION SYSTEM | Ouroboros Medical | 2014-05-01 | Traditional | PDF ↗ |
| K123607 | OCTANE ELEVATE SPINAL IMPLANT SYSTEM | Exactech, Inc. | 2014-04-25 | Traditional | PDF ↗ |
| K140303 | ALAMO T | Alliance Partners, LLC | 2014-04-21 | Special | PDF ↗ |
| K131612 | ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES | GS Medical Co., Ltd. | 2014-04-18 | Traditional | PDF ↗ |
| K140474 | JULIET OL | Spineart | 2014-04-18 | Traditional | PDF ↗ |
| K132738 | COGENT MED-LIF | Cogent Spine, LLC | 2014-04-15 | Traditional | PDF ↗ |
| K133340 | SPINEWORKS ANTERIOR LUMBAR DEVICE | Spineworks, LLC | 2014-04-11 | Traditional | PDF ↗ |
| K140007 | ABACUS TM SPACER SYSTEM | Spine Wave, Inc. | 2014-04-07 | Traditional | PDF ↗ |
| K133614 | ALEUTIAN IBF SYSTEM | K2m, Inc. | 2014-04-03 | Traditional | PDF ↗ |
| K133721 | INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60 | Pinnacle Spine Group, LLC | 2014-03-31 | Traditional | PDF ↗ |
| K133455 | CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC | Pioneer Surgical Technology, Inc. | 2014-03-27 | Traditional | PDF ↗ |
| K134038 | CAMBER SPINE DIAGON OBLIQUE CAGE | Camber Spine | 2014-03-20 | Special | PDF ↗ |
| K133893 | STERISPINE LC CAGE | Safe Orthopaedics | 2014-03-14 | Abbreviated | PDF ↗ |
| K133205 | CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2014-03-13 | Traditional | PDF ↗ |
| K133459 | ELITE IBF | Innova Spinal Technologies, LLC | 2014-03-06 | Traditional | PDF ↗ |
| K133583 | OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070 | Interventional Spine, Inc. | 2014-02-10 | Special | PDF ↗ |
| K133557 | JULIET LL LATERAL LUMBAR CAGE | Spineart | 2014-02-03 | Traditional | PDF ↗ |
| K131292 | DEROYAL SPINE SPACER SYSTEM | Deroyal Industries, Inc. | 2014-02-03 | Traditional | PDF ↗ |
| K133967 | INTERBODY CAGE SYSTEM | Aurora Spine | 2014-01-31 | Traditional | PDF ↗ |
| K133192 | MECTALIF TIPEEK | Medacta International | 2014-01-30 | Traditional | PDF ↗ |
| K133184 | ARDIS INTERBODY SYSTEM | Zimmer Spine, Inc. | 2014-01-30 | Traditional | PDF ↗ |
| K132421 | AESCULAP PEEK XP SPINAL IMPLANT SYSTEM | Aesculap Implant Systems, Inc. | 2014-01-22 | Traditional | PDF ↗ |
| K133371 | RAMPART-L | Spineology, Inc. | 2014-01-09 | Special | PDF ↗ |
| K133645 | PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM, PERIMETER SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2014-01-03 | Traditional | PDF ↗ |
| K132601 | COROENT STERILE IMPLANTS SYSTEM | Nu Vasive, Incorporated | 2013-12-24 | Traditional | PDF ↗ |
| K132790 | INFIX ANTERIOR LUMBAR SYSTEM | Zimmer Spine, Inc. | 2013-12-20 | Traditional | PDF ↗ |
| K133650 | CAPSTONE SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2013-12-20 | Special | PDF ↗ |
| K130913 | GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM | Genesys Spine | 2013-12-13 | Special | PDF ↗ |
| K132897 | CLYDESDALE SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2013-12-11 | Traditional | PDF ↗ |
| K133126 | K7 LUMBAR SPACERS | K7, LLC | 2013-12-09 | Traditional | PDF ↗ |
| K133216 | CRESCENT SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2013-11-22 | Special | PDF ↗ |
| K131669 | PERIMETER INTERBODY FUSION DEVICE | Medtronic Sofamor Danek USA, Inc. | 2013-11-01 | Traditional | PDF ↗ |
| K130274 | BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM | Elite Surgical Supplies (Pty), Ltd. | 2013-10-29 | Traditional | PDF ↗ |
| K131350 | CALIX LUMBAR SPINAL IMPLANT SYSTEM | X-Spine Systems, Inc. | 2013-10-23 | Traditional | PDF ↗ |
| K130254 | PROW FUSION | Nlt Spine, Ltd. | 2013-10-16 | Traditional | PDF ↗ |
| K131178 | IDYS LIF CAGES | Clariance | 2013-10-10 | Traditional | PDF ↗ |
| K131981 | CEZANNE II INTERBODY FUSION SYSTEM | Accel Spine | 2013-10-09 | Traditional | PDF ↗ |
| K132719 | STAXX IBL SYSTEM | Spine Wave, Inc. | 2013-10-04 | Special | PDF ↗ |
| K132700 | PERIMETER INTERBODY FUSION DEVICE | Medtronic Sofamor Danek, Inc. | 2013-09-26 | Special | PDF ↗ |
| K132479 | OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00 | Interventional Spine, Inc. | 2013-09-19 | Special | PDF ↗ |
| K132053 | RAMPART-O, RAMPART-T | Spineology, Inc. | 2013-09-16 | Traditional | PDF ↗ |
| K132505 | ACCULIF TL AND PL CAGE | Coalign Innovations, Inc. | 2013-09-12 | Special | PDF ↗ |
| K131242 | ARDIS INTERBODY SYSTEM | Zimmer Spine, Inc. | 2013-09-03 | Traditional | PDF ↗ |
| K131296 | VARILIFT-L INTERBODY FUSION DEVICE | Wenzel Spine, Inc. | 2013-09-03 | Traditional | PDF ↗ |
| K131540 | INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE | Vertebral Technologies, Inc. | 2013-09-03 | Traditional | PDF ↗ |
| K131082 | INTERFORM INTERBODY CAGE SYSTEM | Next Orthosurgical | 2013-08-26 | Traditional | PDF ↗ |
| K131071 | STAXX IBL SYSTEM | Spine Wave, Inc. | 2013-08-20 | Traditional | PDF ↗ |
| K130820 | EXPANDABLE LUMBAR INTERBODY SYSTEM | Nu Vasive, Incorporated | 2013-08-08 | Traditional | PDF ↗ |
| K130478 | SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS | Globus Medical, Inc. | 2013-07-26 | Traditional | PDF ↗ |
| K123027 | CAPSTONE(R) SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2013-07-25 | Traditional | PDF ↗ |
| K131077 | LIFE SPINE PLATEAU SPACER SYSTEM | Life Spine | 2013-07-17 | Traditional | PDF ↗ |
| K131671 | MECTALIF | Medacta International | 2013-07-05 | Special | PDF ↗ |
| K131372 | MOBIS II | Signus Medizintechnik GmbH | 2013-07-02 | Traditional | PDF ↗ |
| K122957 | TEZO TITANIUM CAGE FAMILY | Ulrich GmbH & Co. KG | 2013-06-21 | Traditional | PDF ↗ |
| K131443 | COALIGN INNOVATIONS ACCULIF XL IBF CAGE | Coalign Innovations, Inc. | 2013-06-19 | Special | PDF ↗ |
| K130630 | PLATEAU SPACER SYSTEM TITANIUM | Life Spine, Inc. | 2013-06-13 | Special | PDF ↗ |
| K124012 | INFILL OBLIQUE TLIF DEVICE | Pinnacle Spine Group, LLC | 2013-06-04 | Traditional | PDF ↗ |
| K130699 | ALEUTIAN SPINAL SYSTEM | K2m, Inc. | 2013-05-30 | Special | PDF ↗ |
| K131216 | RAMPART O | Spineology, Inc. | 2013-05-30 | Special | PDF ↗ |
| K122639 | SYNTHES SYNCAGE EVOLUTION SPACER | Synthes (USA) Products, LLC | 2013-05-24 | Traditional | PDF ↗ |
| K130506 | IMSE P-TLIF | Institute of Musculoskeletal Science & Education | 2013-05-13 | Traditional | PDF ↗ |
| K123913 | LATIS SPACER | Globus Medical, Inc. | 2013-05-13 | Traditional | PDF ↗ |
| K130434 | OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC | Exactech, Inc. | 2013-05-01 | Traditional | PDF ↗ |
| K113781 | PANTHEON SPINAL IBFD SYSTEM | Pantheon Spinal | 2013-04-26 | Traditional | PDF ↗ |
| K130548 | EPICAGE INTERBODY FUSION DEVICE | Alphatec Spine, Inc. | 2013-04-18 | Special | PDF ↗ |
| K123461 | STAXX(R) IB SYSTEM | Spine Wave, Inc. | 2013-04-11 | Traditional | PDF ↗ |
| K123978 | CAPSTONE L SPINAL SYSTEM | Medtronic Sofamor Danek USA | 2013-04-09 | Traditional | PDF ↗ |
| K130194 | ACCULIF XL CAGE | Coalign Innovations, Inc. | 2013-04-03 | Special | PDF ↗ |
| K123997 | TRANS1LATERAL INTERBODY FUSION SYSTEM | Trans1, Inc. | 2013-04-01 | Traditional | PDF ↗ |
| K123100 | INTESS LUMBAR CAGE | Kalitec Direct, LLC | 2013-03-28 | Traditional | PDF ↗ |
| K130396 | RAMPART O AND RAMPART P | Spineology, Inc. | 2013-03-25 | Special | PDF ↗ |
| K122037 | ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST | Medtronic Sofamor Danek, Inc. | 2013-03-22 | Traditional | PDF ↗ |
| K123652 | SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE | Spineology, Inc. | 2013-03-22 | Traditional | PDF ↗ |
| K123602 | TM ARDIS INTERBODY SYSTEM INSERTER | Zimmer Trabecular Metal Technology | 2013-03-01 | Traditional | PDF ↗ |
| K122967 | LUCENT | Spinal Elements, Inc. | 2013-02-21 | Special | PDF ↗ |
| K123969 | XIPHOS | Difusion Technologies | 2013-02-07 | Traditional | PDF ↗ |
| K123281 | ACCULIF TL-PEEK CAGE | Coalign Innovations, Inc. | 2013-01-23 | Traditional | PDF ↗ |
| K120464 | INNESIS PEEK CAGE | Bk Meditech, Co., Ltd. | 2013-01-18 | Traditional | PDF ↗ |
| K123231 | CALIBER SPACERS | Globus Medical, Inc. | 2013-01-18 | Traditional | PDF ↗ |
| K123752 | ACCULIF TL AND PL CAGE | Coalign Innovations, Inc. | 2013-01-14 | Traditional | PDF ↗ |
| K121254 | CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE | Camber Spine Technologies | 2013-01-11 | Traditional | PDF ↗ |
| K123180 | FALCON SPACER | Synthes (USA) Products, LLC | 2013-01-08 | Traditional | PDF ↗ |
| K121693 | A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS) | Sapphire Medical Group, Inc. | 2012-12-27 | Traditional | PDF ↗ |
| K122097 | PATRIOT SPACERS | Globus Medical, Inc. | 2012-12-06 | Special | PDF ↗ |
| K123207 | PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM | Osteomed LP | 2012-11-29 | Traditional | PDF ↗ |
Product code MAX · Class II · Orthopedic. Data: openFDA.