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 3 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K200551 | MectaLIF Transforaminal TiPEEK | Medacta Inernational SA | 2021-02-12 | Traditional | PDF ↗ |
| K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers | Globus Medical, Inc. | 2021-02-02 | Traditional | PDF ↗ |
| K203531 | XYPAN Expandable Lumbar Cage System | Aegis Spine, Inc. | 2021-01-29 | Traditional | PDF ↗ |
| K203327 | VERTACONNECT TLIF Cage | Signus Medizintechnik | 2021-01-25 | Traditional | PDF ↗ |
| K203308 | Ali Interbody Fusion System | Raed M. Ali, M.D., Inc. | 2021-01-15 | Special | PDF ↗ |
| K203683 | CarboClear Lumbar Cage System | Carbofix Orthpedics , Ltd. | 2021-01-15 | Special | PDF ↗ |
| K203201 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System | Nu Vasive, Incorporated | 2021-01-12 | Traditional | PDF ↗ |
| K202495 | SIRION Lateral Lumbar Interbody Fusion | Astura Medical, LLC | 2021-01-06 | Traditional | PDF ↗ |
| K201287 | Impulse Interbody Fusion System | Degen Medical | 2020-12-22 | Traditional | PDF ↗ |
| K202298 | Lucent XP, Lucent XP Curved | Spinal Elements, Inc. | 2020-12-22 | Traditional | PDF ↗ |
| K202820 | Australis Anterior Lumbar Cage System | Prism Surgical Designs Pty, Ltd. | 2020-12-22 | Traditional | PDF ↗ |
| K201755 | WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System | SeaSpine Orthopedics Corporation | 2020-12-15 | Traditional | PDF ↗ |
| K202034 | aprevo Intervertebral Body Fusion Device | Carlsmed, Inc. | 2020-12-03 | Traditional | PDF ↗ |
| K201193 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aPOD-L NanoMetalene; SeaSpine Vu ePOD System; and SeaSpine Reef TH System, SeaSpine Vu aPOD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System | SeaSpine Orthopedics Corporation | 2020-11-25 | Traditional | PDF ↗ |
| K202587 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2020-11-06 | Traditional | PDF ↗ |
| K202198 | FlareHawk Interbody Fusion System | Integrity Implants, Inc. | 2020-11-03 | Traditional | PDF ↗ |
| K200316 | UNiD IB3D ALIF | Medicrea International SA | 2020-10-30 | Traditional | PDF ↗ |
| K201692 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2020-10-29 | Traditional | PDF ↗ |
| K200084 | Zavation IBF System | Zavation Medical Products, LLC | 2020-10-19 | Traditional | PDF ↗ |
| K202305 | Zavation IBF System | Zavation Medical Products, LLC | 2020-10-13 | Traditional | PDF ↗ |
| K201939 | GAIA Lumbar Interbody Fusion Device (LIFD) Family | Printerprezz | 2020-10-08 | Traditional | PDF ↗ |
| K201453 | Fortilink Cages with TiPlus Technology | Paradigm Spine GmbH | 2020-10-07 | Traditional | PDF ↗ |
| K200953 | NuVasive® Cohere® Thoracolumbar Interbody System | Nu Vasive, Incorporated | 2020-10-06 | Traditional | PDF ↗ |
| K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System | Nu Vasive, Incorporated | 2020-09-25 | Traditional | PDF ↗ |
| K201367 | FlareHawk TiHawk9 Interbody Fusion System | Integrity Implants, Inc. | 2020-09-23 | Traditional | PDF ↗ |
| K201145 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | 2020-09-10 | Traditional | PDF ↗ |
| K201721 | TruLift Expandable Spacer System | Life Spine, Inc. | 2020-09-04 | Traditional | PDF ↗ |
| K200958 | MODULIF-A Anterior Lumbar Interbody Fusion System | Spinal Stability, LLC | 2020-08-28 | Traditional | PDF ↗ |
| K192863 | MONDRIAN Lumbar Interbody Fusion Cage System | Ctl Medical Corporation | 2020-08-26 | Traditional | PDF ↗ |
| K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek | 2020-08-26 | Traditional | PDF ↗ |
| K201500 | Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer | Life Spine, Inc. | 2020-08-04 | Traditional | PDF ↗ |
| K201605 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage | Eit Emerging Implant Technologies GmbH | 2020-07-15 | Special | PDF ↗ |
| K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | Innovasis, Inc. | 2020-07-15 | Special | PDF ↗ |
| K193172 | Luna XD Ti Interbody Fusion System | Benvenue Medical, Inc. | 2020-07-02 | Traditional | PDF ↗ |
| K193106 | SpineFrontier Lumbar Interbody Fusion Device System | Spinefrontier, Inc. | 2020-06-19 | Special | PDF ↗ |
| K200283 | Medussa-PL Cage | Medyssey USA, Inc. | 2020-06-18 | Special | PDF ↗ |
| K200879 | SeaSpine Meridian System, SeaSpine Regatta Lateral System | SeaSpine Orthopedics Corporation | 2020-06-10 | Traditional | PDF ↗ |
| K200920 | Idys ALIF ZP 3DTi | Clariance, Sas | 2020-05-29 | Special | PDF ↗ |
| K200969 | NEXXT MATRIXX System | Nexxt Spine, LLC | 2020-05-21 | Special | PDF ↗ |
| K191906 | MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF | MiRus, LLC | 2020-05-18 | Traditional | PDF ↗ |
| K200991 | EVOL Spinal Interbody System | Cutting Edge Spine, LLC | 2020-05-13 | Special | PDF ↗ |
| K193457 | AUDERE Lumbar Spacer System | Met One Technologies | 2020-05-12 | Traditional | PDF ↗ |
| K200816 | SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices | Spineex, Inc. | 2020-04-30 | Special | PDF ↗ |
| K193636 | SeaSpine Reef TH System | SeaSpine Orthopedics Corporation | 2020-04-24 | Traditional | PDF ↗ |
| K200613 | Tritanium® X TL Expandable Curved Posterior Lumbar Cage | Stryker Corporation | 2020-04-15 | Special | PDF ↗ |
| K191353 | COMET Lumbar Interbody Fusion Cage | Baui Biotech Co., Ltd. | 2020-04-14 | Traditional | PDF ↗ |
| K192006 | SIRION Lateral Lumbar Interbody System | Astura Medical, LLC | 2020-04-02 | Traditional | PDF ↗ |
| K200552 | EVOS Lumbar Interbody System | Cutting Edge Spine, LLC | 2020-04-02 | Special | PDF ↗ |
| K193541 | NuVasive Cohere Thoracolumbar Interbody System | Nu Vasive, Incorporated | 2020-03-30 | Traditional | PDF ↗ |
| K191788 | CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | Medtronic Sofamor Danek USA, Inc. | 2020-03-23 | Traditional | PDF ↗ |
| K193418 | SeaSpine Skipjack System | SeaSpine Orthopedics Corporation | 2020-03-13 | Traditional | PDF ↗ |
| K200048 | MectaLIF Anterior Simple | Medacta International S.A. | 2020-03-09 | Traditional | PDF ↗ |
| K193378 | CarboClear Lumbar Cage System | CarboFix Orthopedics , Ltd. | 2020-03-02 | Traditional | PDF ↗ |
| K190363 | Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage | Omnia Medical, LLC | 2020-02-21 | Traditional | PDF ↗ |
| K193255 | Largo PEEK Interbody System | Flospine, LLC | 2020-02-20 | Traditional | PDF ↗ |
| K193203 | MOJAVE Expandable Interbody System | K2m, Inc. | 2020-02-18 | Special | PDF ↗ |
| K193521 | Steerable Plateau Ti | Life Spine, Inc. | 2020-02-06 | Traditional | PDF ↗ |
| K193258 | ProLift Expandable System | Life Spine, Inc. | 2020-01-31 | Traditional | PDF ↗ |
| K192502 | Anatomic PEEK Cervical Fusion System, Anatomic PEEK PTC Cervical Fusion System, Capstone Spinal System, Capstone PTC Spinal System, Capstone Control Spinal System, Capstone Control PTC Spinal System, Clydesdale Spinal System, Clydesdale PTC Spinal System, Cornerstone PSR Cervical Fusion System, Crescent Spinal System, Crescent Spinal System Titanium, Divergence Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L Anterior/Oblique Lumbar Fus | Medtronic Sofamor Danek USA, Inc. | 2020-01-22 | Traditional | PDF ↗ |
| K193370 | Nexxt Matrixx System | Nexxt Spine, LLC | 2020-01-21 | Special | PDF ↗ |
| K192115 | SABLE Expandable Spacer | Globus Medical, Inc. | 2020-01-14 | Traditional | PDF ↗ |
| K193645 | nva, nvp, and nvt | Nvision Biomedical Technologies, Inc. | 2020-01-13 | Special | PDF ↗ |
| K192687 | TrellOss-L MPF | Nexxt Spine, LLC | 2020-01-09 | Traditional | PDF ↗ |
| K192497 | EVOL ha - D Lateral Interbody Fusion System | Cutting Edge Spine, LLC | 2020-01-06 | Traditional | PDF ↗ |
| K192718 | Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2019-12-20 | Traditional | PDF ↗ |
| K181548 | Pantheon Spinal Pontus Interbody Fusion Device | Pantheon Spinal | 2019-12-16 | Traditional | PDF ↗ |
| K193174 | Keos Lumbar IBFD | Keos | 2019-12-16 | Special | PDF ↗ |
| K191796 | Neo Cage System | Neo Medical SA | 2019-12-13 | Traditional | PDF ↗ |
| K182987 | Genesys Spine 3DP Lumbar Interbody System | Genesys Spine | 2019-12-12 | Traditional | PDF ↗ |
| K192132 | SeaSpine Beachside System | SeaSpine Orthopedics Corporation | 2019-12-03 | Traditional | PDF ↗ |
| K192026 | Peridot Intervertebral body fusion System | Gbs Commonwealth Co., Ltd. | 2019-11-26 | Traditional | PDF ↗ |
| K192248 | Cortina [MAX] Lumbar Cage System | Neurostructures, Inc. | 2019-11-25 | Special | PDF ↗ |
| K190721 | LongBow Ti | Life Spine, Inc. | 2019-11-14 | Traditional | PDF ↗ |
| K190544 | XIHPOS ZFUZE Interbody Fusion System | Difusion Technologies | 2019-11-01 | Traditional | PDF ↗ |
| K191134 | IB3D ALIF | Medicrea International SA | 2019-10-30 | Traditional | PDF ↗ |
| K180347 | 3d Cage | Fims Co., Ltd. | 2019-10-28 | Traditional | PDF ↗ |
| K192760 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2019-10-18 | Traditional | PDF ↗ |
| K192434 | DualX Lumbar Intervertebral Body Fusion Device | Amplify Surgical, Inc. | 2019-10-15 | Special | PDF ↗ |
| K191791 | TranS1 Interbody Fusion System | Trans1 | 2019-09-25 | Traditional | PDF ↗ |
| K190483 | SPIRA Open Matrix ALIF and LLIF | Camber Spine Technologies | 2019-09-23 | Traditional | PDF ↗ |
| K190563 | 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage | Solco Biomedical Co., Ltd. | 2019-09-18 | Traditional | PDF ↗ |
| K191391 | HEDRON Lumbar Spacers | Globus Medical, Inc. | 2019-09-18 | Traditional | PDF ↗ |
| K190708 | AccelFix Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2019-09-16 | Traditional | PDF ↗ |
| K190398 | Republic Spine Restore Intervertebral Body Fusion System | Republic Spine, LLC | 2019-09-12 | Traditional | PDF ↗ |
| K191516 | Ali Interbody Fusion System | Raed M. Ali, M.D., Inc. | 2019-09-12 | Traditional | PDF ↗ |
| K183407 | Triton Cage | Medyssey USA, Inc. | 2019-08-30 | Traditional | PDF ↗ |
| K191339 | Zavation eZspand Interbody System | Zavation Medical Products, LLC | 2019-08-19 | Traditional | PDF ↗ |
| K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019-08-12 | Traditional | PDF ↗ |
| K183249 | Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage | Stryker Spine | 2019-07-25 | Traditional | PDF ↗ |
| K190488 | ProLift Expandable System | Life Spine, Inc. | 2019-07-23 | Traditional | PDF ↗ |
| K190680 | FAVO S-TLIF | Silony Medical GmbH | 2019-07-18 | Traditional | PDF ↗ |
| K182158 | UNiD Patient-matched PLIF cage | Medicrea International SA | 2019-07-15 | Traditional | PDF ↗ |
| K191408 | Nexxt Matrixx System | Nexxt Spine, LLC | 2019-07-10 | Special | PDF ↗ |
| K183243 | Velofix TLIF Cage | U&I Corporation | 2019-07-10 | Special | PDF ↗ |
| K191367 | Harrier-SA Lumbar Interbody System | Choice Spine, LLC | 2019-07-05 | Special | PDF ↗ |
| K190498 | Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2019-07-05 | Traditional | PDF ↗ |
| K190959 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology | Medtronic Sofamor Danek USA, Inc. | 2019-07-03 | Traditional | PDF ↗ |
| K183064 | TxTi IBF System | Innovasis, Inc. | 2019-06-28 | Traditional | PDF ↗ |
| K190684 | LxHA PEEK Lateral IBF System | Innovasis, Inc. | 2019-06-17 | Traditional | PDF ↗ |
| K191005 | ProLift® Expandable System | Life Spine, Inc. | 2019-06-13 | Traditional | PDF ↗ |
Product code MAX · Class II · Orthopedic. Data: openFDA.