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 2 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K230851 | Kodiak Lumbar Spacer System | Met One Technologies, LLC | 2023-05-26 | Traditional | PDF ↗ |
| K231140 | aprevo® transforaminal lumbar interbody fusion device | Carlsmed, Inc. | 2023-05-19 | Special | PDF ↗ |
| K230219 | Eminent Spine 3D Lumbar Interbody Fusion Systems | Eminent Spine, LLC | 2023-05-16 | Traditional | PDF ↗ |
| K223335 | SIRION Lateral Lumbar Interbody System | Astura Medical | 2023-05-09 | Traditional | PDF ↗ |
| K223430 | ProLift Micro Expandable Spacer System | Life Spine, Inc. | 2023-05-04 | Traditional | PDF ↗ |
| K223868 | PYXIS 3D Titanium Cage System | GS Medical Co., Ltd. | 2023-04-26 | Traditional | PDF ↗ |
| K223611 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2023-03-29 | Traditional | PDF ↗ |
| K223418 | DeGen Impulse AM System | Degen Medical | 2023-03-17 | Traditional | PDF ↗ |
| K223688 | CONDUIT Lateral Lumbar Intervertebral Fusion Cage, CONDUIT Instruments | Medos International Sàrl | 2023-03-08 | Traditional | PDF ↗ |
| K223776 | PEEK Spinal Infusion Cage | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | 2023-03-03 | Traditional | PDF ↗ |
| K223174 | X-Pac Expandable LLIF Cage System | Expanding Innovations, Inc. | 2023-02-14 | Traditional | PDF ↗ |
| K223474 | PathLoc-TA Expandable Lumbar Cage System | L&K BIOMED Co., Ltd. | 2023-01-13 | Traditional | PDF ↗ |
| K223412 | LumiVy Lumbar IBF System | Vy Spine, LLC | 2023-01-06 | Special | PDF ↗ |
| K223671 | CONDUIT LLIF Straight Inserters | Enztec Limited | 2023-01-05 | Special | PDF ↗ |
| K223654 | Medussa-PL Cage | Medyssey USA, Inc. | 2022-12-28 | Special | PDF ↗ |
| K213653 | 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM | Solco Biomedical Company India Private Limited | 2022-12-19 | Traditional | PDF ↗ |
| K223251 | Hexanium PLIF | Spinevision, S.A.S. | 2022-12-16 | Traditional | PDF ↗ |
| K223153 | Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2022-12-16 | Traditional | PDF ↗ |
| K221182 | Southern Transforaminal Lumbar Interbody Fusion (TLIF) | Southern Medical (Pty) , Ltd. | 2022-12-08 | Traditional | PDF ↗ |
| K221806 | TruLift Lateral Expandable Spacer System & Lateral Plate System | Life Spine, Inc. | 2022-12-05 | Traditional | PDF ↗ |
| K222455 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2022-11-18 | Traditional | PDF ↗ |
| K222732 | WaveForm A Interbody System | SeaSpine Orthopedics Corporation | 2022-11-07 | Traditional | PDF ↗ |
| K221719 | ABTross ALIF Expandable Cage System | Aegis Spine, Inc. | 2022-11-03 | Traditional | PDF ↗ |
| K223065 | Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices | Adcura, Inc. | 2022-10-26 | Special | PDF ↗ |
| K222203 | DualXSLIM(R) T/PLIF | Amplify Surgical, Inc. | 2022-10-18 | Traditional | PDF ↗ |
| K221172 | FOCUS Interbody System | Oc Medical Devices | 2022-10-14 | Traditional | PDF ↗ |
| K221858 | ZSFab Lumbar Interbody System | Zsfab, Inc. | 2022-10-14 | Traditional | PDF ↗ |
| K222797 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | 2022-10-14 | Special | PDF ↗ |
| K222028 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System | Alphatec Spine | 2022-10-07 | Traditional | PDF ↗ |
| K213417 | Ghost Spacer System | Life Spine, Inc. | 2022-09-29 | Traditional | PDF ↗ |
| K213641 | MONDRIAN ALIF Cage with Supplementary Fixation Plate | Ctl Medical Corporation | 2022-09-15 | Traditional | PDF ↗ |
| K220953 | ChoiceSpine TigerShark M, Modular Interbody System | Choice Spine, LLC | 2022-09-13 | Traditional | PDF ↗ |
| K221325 | CONDUIT Lateral Switch Plate | Medos International SARL | 2022-08-25 | Traditional | PDF ↗ |
| K221844 | TDM Lumbar Interbody Fusion Cage System | Tdm Co., Ltd. | 2022-08-17 | Traditional | PDF ↗ |
| K222082 | aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices | Carlsmed, Inc. | 2022-08-12 | Special | PDF ↗ |
| K221687 | Pegasus-X Expandable PLIF System | GS Medical Co., Ltd. | 2022-07-27 | Traditional | PDF ↗ |
| K221535 | Align Lumbar Interbody Fusion System | Acuity Surgical Devices, LLC | 2022-07-22 | Traditional | PDF ↗ |
| K220449 | DePuy CONDUIT LLIF SQUID Inserter | Enztec Limited | 2022-06-28 | Traditional | PDF ↗ |
| K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System | Nu Vasive, Incorporated | 2022-06-21 | Traditional | PDF ↗ |
| K220523 | restor3d TiDAL Lumbar Interbody Fusion Device | Restor3D | 2022-06-17 | Traditional | PDF ↗ |
| K220782 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody System | Alphatec Spine, Inc. | 2022-06-09 | Traditional | PDF ↗ |
| K220581 | Zavation eZspand Interbody System | Zavation Medical Products, LLC | 2022-06-02 | Traditional | PDF ↗ |
| K220902 | Navagio Lumbar Cage | Kalitec Medical, LLC | 2022-05-27 | Traditional | PDF ↗ |
| K220711 | SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System | SeaSpine Orthopedics Corporation | 2022-05-10 | Traditional | PDF ↗ |
| K213420 | WaveForm L System, WaveForm TO System, WaveForm TA System | SeaSpine Orthopedics Corporation | 2022-05-04 | Traditional | PDF ↗ |
| K212477 | EARP Interbody System | Nvision Biomedical Technologies, Inc. | 2022-04-28 | Traditional | PDF ↗ |
| K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA | 2022-04-12 | Traditional | PDF ↗ |
| K212811 | Ti3Z Lumbar Interbody System | Zavation Medical Products, LLC | 2022-04-12 | Traditional | PDF ↗ |
| K213355 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | 2022-03-25 | Traditional | PDF ↗ |
| K220453 | FlareHawk Interbody Fusion System | Integrity Implants, Inc. | 2022-03-24 | Special | PDF ↗ |
| K220655 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | 2022-03-24 | Special | PDF ↗ |
| K213441 | PathLoc Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2022-03-09 | Traditional | PDF ↗ |
| K220096 | Genesys Spine 3DP Lumbar Interbody System | Genesys Spine | 2022-03-09 | Special | PDF ↗ |
| K212930 | LumiVy Lumbar IBF System | Vy Spine, LLC | 2022-02-16 | Traditional | PDF ↗ |
| K213951 | FORZA XP Expandable Spacer System | Orthofix US, LLC | 2022-01-05 | Special | PDF ↗ |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty | Nu Vasive, Incorporated | 2021-12-23 | Traditional | PDF ↗ |
| K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | 2021-12-08 | Traditional | PDF ↗ |
| K212075 | ShurFit Lumbar Interbody System | Precision Spine, Inc. | 2021-12-08 | Traditional | PDF ↗ |
| K212050 | NGM WAVE PLIF Cage | NGMedical GmbH | 2021-12-01 | Traditional | PDF ↗ |
| K212653 | Catalyft LS Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021-11-19 | Traditional | PDF ↗ |
| K211845 | Deploy Expandable Interbody System | Southern Spine, LLC | 2021-11-16 | Traditional | PDF ↗ |
| K212823 | DePuy CONDUIT LLIF Angled Inserters | Enztec Limited | 2021-11-01 | Traditional | PDF ↗ |
| K212389 | Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF | Intelivation, LLC | 2021-10-29 | Traditional | PDF ↗ |
| K212831 | MectaLIF Extension | Medacta International S.A. | 2021-10-29 | Traditional | PDF ↗ |
| K212520 | ProLift Micro Expandable Spacer System | Life Spine, Inc. | 2021-10-08 | Traditional | PDF ↗ |
| K211740 | DualX | Amplify Surgical, Inc. | 2021-09-29 | Special | PDF ↗ |
| K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System | Alphatec Spine, Inc. | 2021-09-22 | Traditional | PDF ↗ |
| K211689 | KEYSTONE PEEK Cage System | Shanghai Sanyou Medical Co, Ltd. | 2021-09-21 | Traditional | PDF ↗ |
| K211474 | Kleiner KG2 System | BAAT Medical Products B.V. | 2021-09-14 | Traditional | PDF ↗ |
| K212540 | Explorer TO System | SeaSpine Orthopedics Corporation | 2021-09-10 | Special | PDF ↗ |
| K203014 | EndoLIF Delta-Cage and DoubleWedge-Cage | Joimax GmbH | 2021-09-01 | Traditional | PDF ↗ |
| K212070 | KMTI S141 Lumbar Interbody Fusion System | Kyocera Medical Technologies, Inc. | 2021-08-30 | Special | PDF ↗ |
| K210090 | Impulse AM Interbody Fusion System | Degen Medical | 2021-08-30 | Traditional | PDF ↗ |
| K211413 | BEE PLIF Cage | NGMedical GmbH | 2021-08-27 | Traditional | PDF ↗ |
| K210800 | IO Expandable Lumbar Interbody Fusion System | MiRus, LLC | 2021-08-20 | Traditional | PDF ↗ |
| K211873 | PSX Interbody System | Alphatec Spine, Inc. | 2021-08-10 | Traditional | PDF ↗ |
| K211388 | Lateral Spine Truss System (LSTS) Interbody Fusion Device | 4Web Medical, Inc. | 2021-08-05 | Special | PDF ↗ |
| K210497 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aPOD-L NanoMetalene, SeaSpine Vu ePOD System, SeaSpine Vu aPOD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System | SeaSpine Orthopedics Corporation | 2021-07-07 | Special | PDF ↗ |
| K203003 | Pantheon IBFD | Pantheon Spinal | 2021-07-07 | Special | PDF ↗ |
| K210044 | Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System | Spinal Elements, Inc. | 2021-06-30 | Traditional | PDF ↗ |
| K210542 | aprevo Transforaminal IBF | Carlsmed, Inc. | 2021-06-30 | Traditional | PDF ↗ |
| K211306 | LABYRINTH | Zavation Medical Products, LLC | 2021-06-24 | Traditional | PDF ↗ |
| K210595 | SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers | Camber Spine Technologies, LLC | 2021-06-15 | Traditional | PDF ↗ |
| K203802 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | 2021-06-07 | Traditional | PDF ↗ |
| K210583 | SeaSpine WaveForm A Interbody System | SeaSpine Orthopedics Corporation | 2021-06-02 | Traditional | PDF ↗ |
| K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021-05-26 | Special | PDF ↗ |
| K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2021-05-24 | Traditional | PDF ↗ |
| K210214 | NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System | Nu Vasive, Incorporated | 2021-05-24 | Traditional | PDF ↗ |
| K210439 | NuVasive MOD-EX XLIF Interbody System | Nu Vasive, Incorporated | 2021-05-12 | Traditional | PDF ↗ |
| K210728 | CONDUIT Instruments | Medos International SARL | 2021-05-06 | Traditional | PDF ↗ |
| K210061 | ProLift Lateral HELO Fixated | Life Spine, Inc. | 2021-04-30 | Traditional | PDF ↗ |
| K201024 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, LLC | 2021-04-29 | Traditional | PDF ↗ |
| K200919 | Idys ALIF 3DTi | Clariance | 2021-04-12 | Traditional | PDF ↗ |
| K203254 | Lucent 3D Spinal System | Spinal Elements, Inc. | 2021-03-26 | Traditional | PDF ↗ |
| K203038 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | 2021-03-26 | Traditional | PDF ↗ |
| K203361 | ProLift Wedge Expandable Spacer System | Life Spine, Inc. | 2021-03-17 | Traditional | PDF ↗ |
| K210359 | Hexanium TLIF | Spinevision, S.A.S. | 2021-03-10 | Special | PDF ↗ |
| K203576 | FORZA Ti Spacer System | Orthofix, Inc. | 2021-03-03 | Traditional | PDF ↗ |
| K210155 | Duo Expandable Interbody Fusion System | Spineology, Inc. | 2021-02-19 | Special | PDF ↗ |
| K202380 | Born PT-LIF Cage HA | Spineworxx AG | 2021-02-19 | Traditional | PDF ↗ |
Product code MAX · Class II · Orthopedic. Data: openFDA.