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 4 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K183560 | Luna 3D GEN2 Interbody Fusion System | Benvenue Medical, Inc. | 2019-05-23 | Traditional | PDF ↗ |
| K190092 | UNiD Patient specific 3D printed TLIF cage | Medicrea International SA | 2019-05-08 | Traditional | PDF ↗ |
| K190165 | Capstone Control Spinal System | Medtronic Sofamor Danek USA, Inc. | 2019-05-06 | Traditional | PDF ↗ |
| K182877 | HALF DOME Posterior Lumbar Interbody System | Astura Medical, LLC | 2019-05-03 | Traditional | PDF ↗ |
| K190364 | CancelleX Porous Titanium Lumbar Interbody Device | Xenco Medical, LLC | 2019-04-18 | Traditional | PDF ↗ |
| K183184 | FlareHawk Interbody Fusion System | Integrity Implants, Inc. | 2019-04-03 | Traditional | PDF ↗ |
| K182349 | CONCORDE LIFT | Medos International SARL | 2019-04-03 | Traditional | PDF ↗ |
| K182920 | MiRus Lumbar Interbody Fusion System consisting of CALLISTO PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES PEEK Anterior Lumbar Interbody Fusion (ALIF) | MiRus, LLC | 2019-03-13 | Traditional | PDF ↗ |
| K183092 | Kuros TLIF Cage | Kuros Biosciences B.V | 2019-03-08 | Traditional | PDF ↗ |
| K173518 | Spectrum Spine Expandable Cages (SSEC) | Spectrum Spine, LLC | 2019-03-07 | Traditional | PDF ↗ |
| K190055 | Duo Lumbar Interbody Fusion Device | Spineology, Inc. | 2019-03-07 | Special | PDF ↗ |
| K190193 | SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices | Spineex, Inc. | 2019-03-04 | Special | PDF ↗ |
| K183259 | Idys TLIF TiVac | Clariance, Sas | 2019-03-01 | Traditional | PDF ↗ |
| K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019-03-01 | Traditional | PDF ↗ |
| K182406 | Altus Spine Interbody Fusion System | Altus Partners, LLC | 2019-02-22 | Traditional | PDF ↗ |
| K183049 | Reliance Lumbar IBF System | Reliance Medical Systems, LLC | 2019-02-15 | Special | PDF ↗ |
| K183659 | Omnia Medical Rotary PLIF System | Omnia Medical, LLC | 2019-02-06 | Traditional | PDF ↗ |
| K183447 | EIT Cellular Titanium Lumbar Cage - T/PLIF | Eit Emerging Implant Technologies GmbH | 2019-02-04 | Traditional | PDF ↗ |
| K181048 | Neo Cage System TM | Neo Medical SA | 2019-01-29 | Traditional | PDF ↗ |
| K180822 | VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System | Wenzel Spine, Inc. | 2019-01-28 | Traditional | PDF ↗ |
| K180230 | NEST Interbody System | Paonan Biotech Co., Ltd. | 2019-01-25 | Traditional | PDF ↗ |
| K180228 | II-Type Intervertebral Spacer | Paonan Biotech Co., Ltd. | 2019-01-11 | Traditional | PDF ↗ |
| K182210 | TiWAVE-L Porous Titanium Lumbar Cage | Kalitec Medical, LLC | 2019-01-07 | Traditional | PDF ↗ |
| K182114 | FlareHawk Interbody Fusion System | Integrity Implants, Inc. | 2019-01-07 | Traditional | PDF ↗ |
| K181589 | Curiteva Lumbar Interbody Fusion System | Curiteva, LLC | 2018-12-20 | Traditional | PDF ↗ |
| K183239 | CoreLink F3D Lateral System | Corelink, LLC | 2018-12-19 | Special | PDF ↗ |
| K181899 | ROCCIA® PLIF | Silony Medical GmbH | 2018-12-13 | Traditional | PDF ↗ |
| K181625 | Life Spine Resolute Threaded Cage System | Life Spine, Inc. | 2018-12-11 | Traditional | PDF ↗ |
| K182584 | Lucent® XP | Spinal Elements, Inc. | 2018-12-10 | Traditional | PDF ↗ |
| K181231 | DePuy Synthes T-PAL Spacer System | Depuy Synthes Spine | 2018-12-06 | Traditional | PDF ↗ |
| K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | Globus Medical, Inc. | 2018-12-06 | Traditional | PDF ↗ |
| K181970 | MectaLIF Posterior Extension | Medacta International S.A. | 2018-12-04 | Traditional | PDF ↗ |
| K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018-11-27 | Traditional | PDF ↗ |
| K182470 | Plateau Spacer System | Life Spine | 2018-11-26 | Traditional | PDF ↗ |
| K181963 | ostaPek Interbody Fusion Cages | Coligne AG | 2018-11-14 | Traditional | PDF ↗ |
| K181829 | Velofix TLIF Cage | U&I Corporation | 2018-11-14 | Special | PDF ↗ |
| K181837 | Spinal Elements Ti-Bond coated devices | Spinal Elements, Inc. | 2018-11-02 | Traditional | PDF ↗ |
| K182322 | Duo Lumbar Interbody Fusion Device | Spineology, Inc. | 2018-10-24 | Traditional | PDF ↗ |
| K181644 | EIT Cellular Titanium® Lumbar Cage LLIF | Eit Emerging Implant Technologies GmbH | 2018-10-12 | Traditional | PDF ↗ |
| K181860 | NuVasive Cohere Thoracolumbar Interbody System | Nu Vasive, Incorporated | 2018-10-05 | Traditional | PDF ↗ |
| K181531 | SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices | Spineex, Inc. | 2018-10-05 | Traditional | PDF ↗ |
| K181397 | DualX | Innovasive, Inc. | 2018-09-27 | Traditional | PDF ↗ |
| K181591 | Fixated Asfora BULLET CAGE® (FABC) | Medical Designs, LLC | 2018-09-26 | Traditional | PDF ↗ |
| K181702 | Tranquil-L Interbody System | Nexus Spine, LLC | 2018-09-21 | Traditional | PDF ↗ |
| K181337 | Sypher Spacer System | Biogennix, LLC | 2018-09-18 | Traditional | PDF ↗ |
| K181655 | Renovis S180 Lateral Lumbar Interbody Fusion System | Renovis Surgical Technologies | 2018-09-11 | Traditional | PDF ↗ |
| K181380 | LnK Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2018-09-11 | Traditional | PDF ↗ |
| K181483 | Tranquil Interbody System | Nexus Spine, LLC | 2018-08-27 | Traditional | PDF ↗ |
| K180373 | CancelleX Porous Titanium Lumbar Interbody Device | Xenco Medical, LLC | 2018-08-24 | Traditional | PDF ↗ |
| K181347 | Aries® Lumbar Interbodies | Osseus Fusion Systems, LLC | 2018-08-15 | Traditional | PDF ↗ |
| K181792 | Duo Lumbar Interbody Fusion Device | Spineology, Inc. | 2018-08-14 | Special | PDF ↗ |
| K180990 | TirboLOX-L Lumbar IBFD | Captiva Spine, Inc. | 2018-08-13 | Traditional | PDF ↗ |
| K180777 | K2M Expandable Interbody System | K2m, Inc. | 2018-08-03 | Traditional | PDF ↗ |
| K180076 | Ti 3Z Interbody System | Zavation Medical Products, LLC | 2018-07-27 | Traditional | PDF ↗ |
| K180556 | Corelink Foundation 3D Anterior Lumbar System | Corelink, LLC | 2018-07-27 | Special | PDF ↗ |
| K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018-07-25 | Traditional | PDF ↗ |
| K173947 | Lumbar Interbody Fusion System (OLLIF) | Advanced Research Medical, LLC | 2018-07-25 | Traditional | PDF ↗ |
| K181079 | SeaSpine Regatta Lateral System | SeaSpine Orthopedics Corporation | 2018-07-18 | Traditional | PDF ↗ |
| K181014 | Tritanium PL Cage | Stryker Spine | 2018-07-18 | Traditional | PDF ↗ |
| K181030 | Rubicon Lumbar Interbody Fusion System | Rubicon Spine, LLC | 2018-07-17 | Traditional | PDF ↗ |
| K180963 | ROCCIA ALIF, ROCCIA TLIF | Silony Medical GmbH | 2018-07-11 | Traditional | PDF ↗ |
| K181246 | Zavation IBF System | Zavation Medical Products, LLC | 2018-07-10 | Traditional | PDF ↗ |
| K173864 | Peekplus® Interbody Fusion Device | Vallum Corporation | 2018-07-02 | Traditional | PDF ↗ |
| K181203 | Juliet Ti | Spineart | 2018-06-28 | Special | PDF ↗ |
| K180724 | SPIRA Open Matrix LLIF | Camber Spine Technologies, LLC | 2018-06-25 | Traditional | PDF ↗ |
| K173189 | Lumfuse TP | Precifit Medical, Ltd. | 2018-06-08 | Traditional | PDF ↗ |
| K180687 | Reliance Lumber IBF System | Reliance Medical Systems | 2018-05-15 | Special | PDF ↗ |
| K173347 | STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX | Centinel Spine, Inc. | 2018-05-08 | Traditional | PDF ↗ |
| K173892 | NuVasive® XLX Interbody System | Nu Vasive, Incorporated | 2018-05-04 | Traditional | PDF ↗ |
| K180891 | EVOL Spinal Interbody System, EVOS Lumbar Interbody System | Cutting Edge Spine, LLC | 2018-05-04 | Special | PDF ↗ |
| K180437 | Hexanium® TLIF | Spinevision, S.A.S. | 2018-05-04 | Traditional | PDF ↗ |
| K180071 | STYLO Interbody Fusion Device | Legend Spine Technologies | 2018-05-03 | Traditional | PDF ↗ |
| K171151 | ACRON TLIF System | Spinemed Ges.M.B.H | 2018-04-27 | Traditional | PDF ↗ |
| K173782 | UNiD Patient Specific 3D printed cage | Medicrea International SA | 2018-04-25 | Traditional | PDF ↗ |
| K172947 | HALF DOME Posterior Lumbar Interbody System | Astura Medical | 2018-04-18 | Special | PDF ↗ |
| K180078 | Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System | Innovasis, Inc. | 2018-04-17 | Traditional | PDF ↗ |
| K180431 | Cortina [MAX] Lumbar Cage System | Neurostructures, Inc. | 2018-03-22 | Traditional | PDF ↗ |
| K171495 | Zyston Strut Open Titanium Spacer System | Zimmer Biomet Spine, Inc. | 2018-02-12 | Traditional | PDF ↗ |
| K173025 | NuVasive® MLX® Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF System | Nu Vasive, Incorporated | 2018-02-08 | Traditional | PDF ↗ |
| K173537 | CONCORDE LIFT | Medos International SARL | 2018-02-08 | Traditional | PDF ↗ |
| K172105 | The Plateau-LO Spacer System | Life Spine, Inc. | 2018-02-02 | Traditional | PDF ↗ |
| K172828 | Double Medical Cage System | Double Medical Technology, Inc. | 2018-02-01 | Traditional | PDF ↗ |
| K172816 | TiGer Shark System | Choicespine, LP | 2018-01-26 | Traditional | PDF ↗ |
| K171312 | FortiCore® | Nanovis, LLC | 2018-01-22 | Traditional | PDF ↗ |
| K172696 | FORZA® XP Expandable Spacer System | Orthofix, Inc. | 2018-01-19 | Traditional | PDF ↗ |
| K173283 | Reliance Lumbar IBF System | Reliance Medical Systems, LLC | 2018-01-19 | Special | PDF ↗ |
| K173476 | Tritanium® TL Curved Posterior Lumbar Cage | Stryker | 2018-01-18 | Traditional | PDF ↗ |
| K173702 | Juliet Ti LL | Spineart | 2018-01-03 | Special | PDF ↗ |
| K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE Spacers | Globus Medical, Inc. | 2017-12-21 | Traditional | PDF ↗ |
| K171434 | ROCCIA® MultiLIF | Silony Medical GmbH | 2017-12-21 | Traditional | PDF ↗ |
| K173182 | ProLift® Expandable System | Life Spine, Inc. | 2017-12-20 | Traditional | PDF ↗ |
| K172465 | Idys TLIF 3DTi Cages | Clariance, Sas | 2017-12-15 | Traditional | PDF ↗ |
| K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages | Eit Emerging Implant Technologies GmbH | 2017-12-15 | Traditional | PDF ↗ |
| K170389 | TAURUS PEEK Cage System | Medyssey USA, Inc. | 2017-12-14 | Traditional | PDF ↗ |
| K172349 | InFill® Interbody Fusion Device | Pinnacle Spine Group, LLC | 2017-12-14 | Traditional | PDF ↗ |
| K172009 | Cascadia Interbody System | K2m, Inc. | 2017-12-14 | Traditional | PDF ↗ |
| K172756 | Varian cage | Medyssey USA, Inc. | 2017-12-08 | Traditional | PDF ↗ |
| K173153 | Vertera Spine Coalesce Thoracolumbar Interbody Fusion System | Nu Vasive, Incorporated | 2017-12-06 | Traditional | PDF ↗ |
| K173260 | SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System | SeaSpine Orthopedics Corporation | 2017-12-04 | Traditional | PDF ↗ |
| K172419 | Velofix TLIF Cage | U&I Corporation | 2017-12-04 | Traditional | PDF ↗ |
Product code MAX · Class II · Orthopedic. Data: openFDA.