FDA Product Code
FDA Product Code KWQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3060
510(k) Clearances — 668 records · page 1 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262149 | corra® cervical plating system | Carlsmed, Inc. | 2026-09-24 | Traditional | PDF ↗ |
| K261309 | Palisades Buttress Plate System | Bethesda Medical Devices, LLC | 2026-07-16 | Traditional | PDF ↗ |
| K252776 | ARIES Anterior Cervical Plate Systems | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-14 | Traditional | PDF ↗ |
| K261112 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2026-05-06 | Special | PDF ↗ |
| K260570 | corra cervical plating system | Carlsmed, Inc. | 2026-04-22 | Traditional | PDF ↗ |
| K260697 | VyPlate Anterior Cervical Plate System | Vy Spine, LLC | 2026-03-27 | Special | PDF ↗ |
| K260015 | ANTERIS Thoracolumbar Plate System | SpineCraft | 2026-03-04 | Traditional | PDF ↗ |
| K251940 | PathLoc Lumbar Plate System | L&K BIOMED Co., Ltd. | 2026-03-03 | Traditional | PDF ↗ |
| K254182 | Aster | Osteonic Co., Ltd. | 2026-02-26 | Traditional | PDF ↗ |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | 4Web, Inc. | 2026-02-12 | Special | PDF ↗ |
| K252611 | aprevo® cervical plating system | Carlsmed, Inc. | 2025-12-22 | Traditional | PDF ↗ |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | Alphatec Spine, Inc. | 2025-08-28 | Traditional | PDF ↗ |
| K251436 | Resolve Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2025-07-11 | Abbreviated | PDF ↗ |
| K250446 | Frida Anterior Cervical Plate System | Spineup, Inc. | 2025-05-23 | Traditional | PDF ↗ |
| K250602 | X-PAC® N-GAGE Lumbar Plate System | Expanding Innovations, Inc. | 2025-05-20 | Traditional | PDF ↗ |
| K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2025-04-10 | Special | PDF ↗ |
| K243904 | Elegance® Anterior Cervical plate | Clariance | 2025-01-14 | Special | PDF ↗ |
| K243369 | Cervical Plating System | Life Spine, Inc. | 2024-12-11 | Traditional | PDF ↗ |
| K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI | Stryker Spine | 2024-11-07 | Traditional | PDF ↗ |
| K243015 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | 2024-11-05 | Traditional | PDF ↗ |
| K231251 | FlexWing Anterior Cervical Plate System | Jeil Medical Corporation | 2024-07-24 | Traditional | PDF ↗ |
| K240592 | Wolff's Law Anterior Cervical Plate System | Spinal Simplicity, LLC | 2024-05-24 | Traditional | PDF ↗ |
| K240935 | ARENAL Anterior Cervical Plate System | Effortmed, LLC | 2024-05-17 | Traditional | PDF ↗ |
| K233215 | icotec Anterior Cervical Plate System | Icotec AG | 2024-05-17 | Traditional | PDF ↗ |
| K241175 | MiRus MoRe Lumbar Plating System | MiRus, LLC | 2024-05-17 | Traditional | PDF ↗ |
| K240484 | MSFX Mikron Cervical Anterior Plate System | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2024-04-17 | Traditional | PDF ↗ |
| K232256 | Alcantara Thoracolumbar Plate System | Camber Spine Technologies, LLC | 2024-04-16 | Traditional | PDF ↗ |
| K240423 | TDM Anterior Cervical Plate System | Tdm Co., Ltd. | 2024-04-08 | Traditional | PDF ↗ |
| K240690 | STRUXXURE® MCS Anterior Cervical Plate System | Nexxt Spine | 2024-03-22 | Special | PDF ↗ |
| K240515 | uNion® MAX Cervical Plate System | Ulrich Medical USA, Inc. | 2024-03-18 | Special | PDF ↗ |
| K233360 | Curiteva Thoracolumbar Plate System | Curiteva, Inc. | 2024-02-29 | Traditional | PDF ↗ |
| K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System | Alphatec Spine, Inc. | 2024-02-22 | Traditional | PDF ↗ |
| K231715 | MONDRIAN Anterior Lumbar Plate System | Ctl Medical Corporation | 2024-01-26 | Traditional | PDF ↗ |
| K233735 | ADIRA Lateral Plate System | Globus Medical, Inc. | 2024-01-25 | Traditional | PDF ↗ |
| K232318 | VICTORY Lumbar Plate System | Globus Medical, Inc. | 2023-10-31 | Traditional | PDF ↗ |
| K231766 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2023-09-12 | Traditional | PDF ↗ |
| K231593 | Sapphire X3 Anterior Cervical Plate System | Spinal Elements, Inc. | 2023-08-02 | Traditional | PDF ↗ |
| K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. | 2023-07-19 | Special | PDF ↗ |
| K231460 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM & BALTEUM-ONE Lumbar Plate System, and Osprey Anterior Cervical Plate System | K&J Consulting Corp. | 2023-07-16 | Traditional | PDF ↗ |
| K230993 | CODA Anterior Cervical Plate System | Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech | 2023-06-20 | Special | PDF ↗ |
| K231090 | Zevo Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | 2023-06-15 | Traditional | PDF ↗ |
| K231145 | Axis Anterior Cervical Plate System | Southern Medical (Pty) , Ltd. | 2023-06-13 | Traditional | PDF ↗ |
| K230721 | ATEC Lateral Plate System | Alphatec Spine, Inc. | 2023-05-09 | Traditional | PDF ↗ |
| K230424 | Omnia Medical Coupler-A Anterior Lumbar Plate System; Omnia Medical Coupler-L Lateral Lumbar Plate System | Omnia Medical, LLC | 2023-04-12 | Traditional | PDF ↗ |
| K223753 | Cervical Plate System | Double Medical Technology, Inc. | 2023-03-14 | Traditional | PDF ↗ |
| K223321 | Omnia Medical Coupler-C Anterior Cervical Plate | Omnia Medical, LLC | 2023-03-13 | Traditional | PDF ↗ |
| K230301 | Athena III Cervical Plate System | Medyssey USA, Inc. | 2023-03-07 | Special | PDF ↗ |
| K221053 | Magnes-C Anterior Cervical Plate System | Fellowship of Orthopaedic Researchers, Inc. | 2023-03-01 | Traditional | PDF ↗ |
| K223627 | PreView-III Anterior Cervical Plate System | Nexus Spine, LLC | 2023-02-02 | Traditional | PDF ↗ |
| K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System | Aegis Spine, Inc. | 2023-01-11 | Special | PDF ↗ |
| K220843 | OAKTREE Anterior Lumbar Plate and Screw System | Oak Tree Engineering, LLC | 2022-12-07 | Traditional | PDF ↗ |
| K222493 | CODA Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2022-11-18 | Traditional | PDF ↗ |
| K222628 | Life Spine ALIF Buttress Plate System | Life Spine, Inc. | 2022-11-16 | Traditional | PDF ↗ |
| K220334 | MONET Anterior Cervical Plate System | Ctl Medical Corporation | 2022-11-09 | Traditional | PDF ↗ |
| K221728 | Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran Anterior Cervical Plating (ACP) System, Reflex Hybrid ACP System, UniVise Spinous Process Fixation Plate | Stryker Corporation | 2022-10-19 | Traditional | PDF ↗ |
| K222572 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM & BALTEUM-ONE Lumbar Plate System | Dio Medical Corporation | 2022-10-18 | Traditional | PDF ↗ |
| K220441 | CYGNUS MoRe Anterior Cervical Plate System | MiRus, LLC | 2022-09-16 | Traditional | PDF ↗ |
| K221572 | VyPlate Anterior Cervical Plate System | Vy Spine, LLC | 2022-07-26 | Traditional | PDF ↗ |
| K211718 | Venus Cervical Plate System | Artfx Medical, LLC | 2022-06-28 | Traditional | PDF ↗ |
| K212527 | Cervical Spine Truss System Plating Solution (CSTS-PS) | 4Web Medical, Inc. | 2022-05-17 | Traditional | PDF ↗ |
| K220182 | Aggeris-C | Clariance | 2022-03-30 | Traditional | PDF ↗ |
| K213820 | BALTEUM - ONE Lumbar Plate System | Huvexel Co. , Ltd. | 2022-03-25 | Traditional | PDF ↗ |
| K220275 | EMERGE Anterior Cervical Plate System | Evolution Spine | 2022-03-18 | Traditional | PDF ↗ |
| K220324 | AccuFit Lateral 2-Hole Plate | Precision Spine, Inc. | 2022-03-16 | Traditional | PDF ↗ |
| K220379 | IMPEACE and IMPEACE-Uni Anterior Cervical Plate System | Medynus, Inc. | 2022-03-03 | Traditional | PDF ↗ |
| K220147 | Aspiron S ACP System | U&I Corporation | 2022-02-16 | Special | PDF ↗ |
| K211712 | 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System | Orthofix US, LLC | 2022-02-11 | Traditional | PDF ↗ |
| K213901 | Cyclops Anterior Cervical Plate System | Degen Medical | 2022-01-07 | Special | PDF ↗ |
| K213219 | Vy Spine VyWasher Buttress System | Vy Spine, LLC | 2021-12-23 | Traditional | PDF ↗ |
| K213456 | Xenco Medical Multilevel CerviKit | Xenco Medical, LLC | 2021-12-21 | Traditional | PDF ↗ |
| K213443 | Insignia Anterior Cervical Plate System | Alphatec Spine, Inc. | 2021-12-15 | Traditional | PDF ↗ |
| K212937 | Dakota ALIF Plate System | Precision Spine, Inc. | 2021-11-04 | Traditional | PDF ↗ |
| K212446 | NuVasive Anterior Cervical Plate Systems | Nu Vasive, Incorporated | 2021-11-03 | Traditional | PDF ↗ |
| K210424 | Quantum Anterior Cervical Plate | Nvision Biomedical Technologies, Inc. | 2021-10-22 | Traditional | PDF ↗ |
| K212405 | EMERGE Anterior Cervical Plate System | Evolution Spine | 2021-09-30 | Abbreviated | PDF ↗ |
| K212139 | Admiral ACP System | SeaSpine Orthopedics Corporation | 2021-09-01 | Traditional | PDF ↗ |
| K211903 | Shoreline Threaded TruProfile® Plate | SeaSpine Orthopedics Corporation | 2021-08-30 | Traditional | PDF ↗ |
| K211205 | Prase-C Anterior Cervical Plate System | Gbs Commonwealth Co., Ltd. | 2021-08-12 | Traditional | PDF ↗ |
| K211932 | Fixxsure Anterior Lumbar Plate and Screw System | Oak Tree Engineering, LLC | 2021-07-27 | Traditional | PDF ↗ |
| K211408 | CervAlign® Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2021-06-23 | Traditional | PDF ↗ |
| K210182 | PANAMA Anterior Cervical Plate (ACP) System | Flospine | 2021-04-07 | Traditional | PDF ↗ |
| K210325 | APOLLO Anterior Cervical Plate (ACP) System | Aurora Spine, Inc. | 2021-03-23 | Traditional | PDF ↗ |
| K210286 | Cure 2.0 Anterior Cervical Plate (ACP) System | Meditech Spine, LLC | 2021-03-18 | Special | PDF ↗ |
| K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS) | 4Web, Inc. | 2021-03-10 | Traditional | PDF ↗ |
| K202878 | Prase-AP Anterior Cervical Plate System | Gbs Commonwealth Co., Ltd. | 2021-01-29 | Traditional | PDF ↗ |
| K203253 | NuVasive ACP System | Nu Vasive, Incorporated | 2020-12-03 | Special | PDF ↗ |
| K202972 | Anterior Cervical Plate System | Nutech Spine and Biologics | 2020-11-24 | Traditional | PDF ↗ |
| K203154 | KASILOF Cervical Plate System | Kahtnu Surgical, Inc. | 2020-11-05 | Special | PDF ↗ |
| K202624 | Z-Span Plate System | Zavation Medical Products, LLC | 2020-11-04 | Traditional | PDF ↗ |
| K201587 | icotec Anterior Cervical Plate System | Icotec AG | 2020-10-15 | Traditional | PDF ↗ |
| K202309 | Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System | Zimmer Biomet Spine, Inc. | 2020-10-08 | Traditional | PDF ↗ |
| K202192 | STRUXXURE®-L and STRUXXURE®-A Plate System | Nexxt Spine, LLC | 2020-09-17 | Traditional | PDF ↗ |
| K202227 | Artus cervical plate system | Ulrich GmbH & Co. KG | 2020-09-14 | Traditional | PDF ↗ |
| K202064 | Admiral ACP System | SeaSpine Orthopedics Corporation | 2020-08-26 | Traditional | PDF ↗ |
| K201979 | Cervical Plate System | Eminent Spine, LLC | 2020-08-25 | Traditional | PDF ↗ |
| K201521 | Medina Anterior Cervical Plate System | Alliance Partners, LLC | 2020-08-06 | Traditional | PDF ↗ |
| K201079 | Aurora® Anterior Lumbar Plate Sytstem | Prism Surgical Design Pty , Ltd. | 2020-08-05 | Traditional | PDF ↗ |
| K192481 | AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. | 2020-07-28 | Traditional | PDF ↗ |
| K200927 | Transept Cervical Plate System | Neurostructures, Inc. | 2020-07-24 | Traditional | PDF ↗ |
| K201029 | Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System | Spinal Elements, Inc. | 2020-06-17 | Traditional | PDF ↗ |
Product code KWQ · Class II · Orthopedic. Data: openFDA.