Atlas FDA

KWQ

667 FDA 510(k) clearances · Product code

84 daysmedian time to decision
246 days90th percentile
667clearances measured

FDA profile

Official device name
Appliance, Fixation, Spinal Intervertebral Body
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3060
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 591 · 2022: 392 · 2023: 320 · 2024: 419 · 2025: 251 · 2026: 234
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Palisades™ Buttress Plate System (K261309)Bethesda Medical Devices, LLC2026-07-16
ARIES Anterior Cervical Plate Systems (K252776)ZheJiang Decans Medical Devices Co., Ltd.2026-05-14
CastleLoc-P Anterior Cervical Plate System (K261112)L&K BIOMED Co., Ltd.2026-05-06
corra™ cervical plating system (K260570)Carlsmed, Inc.2026-04-22
VyPlate™ Anterior Cervical Plate System (K260697)Vy Spine, LLC2026-03-27
ANTERIS Thoracolumbar Plate System (K260015)SpineCraft2026-03-04
PathLoc Lumbar Plate System (K251940)L&K BIOMED Co., Ltd.2026-03-03
Aster (K254182)Osteonic Co., Ltd.2026-02-26
Lumbar Spine Truss System - Plating Solution (LSTS-PS) (K253201)4Web, Inc.2026-02-12
aprevo® cervical plating system (K252611)Carlsmed, Inc.2025-12-22
Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (K251965)Alphatec Spine, Inc.2025-08-28
Resolve Anterior Cervical Plate System (K251436)Pioneer Surgical Technology, Inc.2025-07-11
Frida™ Anterior Cervical Plate System (K250446)Spineup, Inc.2025-05-23
X-PAC® N-GAGE™ Lumbar Plate System (K250602)Expanding Innovations, Inc.2025-05-20
Skyway Anterior Cervical Plate System (K250486)Kyocera Medical Technologies Inc. (KMTI)2025-04-10
Elegance® Anterior Cervical plate (K243904)Clariance2025-01-14
Cervical Plating System (K243369)Life Spine, Inc.2024-12-11
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 (K242361)Stryker Spine2024-11-07
Skyway Anterior Cervical Plate System (K243015)Kyocera Medical Technologies, Inc.2024-11-05
FlexWing Anterior Cervical Plate System (K231251)Jeil Medical Corporation2024-07-24
Wolff's Law Anterior Cervical Plate System (K240592)Spinal Simplicity, LLC2024-05-24
ARENAL Anterior Cervical Plate System (K240935)Effortmed, LLC2024-05-17
MiRus MoRe Lumbar Plating System (K241175)MiRus, LLC2024-05-17
icotec Anterior Cervical Plate System (K233215)Icotec AG2024-05-17
MSFX Mikron Cervical Anterior Plate System (K240484)Mikron Makina Sanayi VE Ticaret Ltd. Sti.2024-04-17
Alcantara Thoracolumbar Plate System (K232256)Camber Spine Technologies, LLC2024-04-16
TDM Anterior Cervical Plate System (K240423)Tdm Co., Ltd.2024-04-08
STRUXXURE® MCS Anterior Cervical Plate System (K240690)Nexxt Spine2024-03-22
uNion® MAX Cervical Plate System (K240515)Ulrich Medical USA, Inc.2024-03-18
Curiteva Thoracolumbar Plate System (K233360)Curiteva, Inc.2024-02-29
Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System (K233640)Alphatec Spine, Inc.2024-02-22
MONDRIAN™ Anterior Lumbar Plate System (K231715)Ctl Medical Corporation2024-01-26
ADIRA™ Lateral Plate System (K233735)Globus Medical, Inc.2024-01-25
VICTORY™ Lumbar Plate System (K232318)Globus Medical, Inc.2023-10-31
Skyway Anterior Cervical Plate System (K231766)Kyocera Medical Technologies Inc. (KMTI)2023-09-12
Sapphire X3 Anterior Cervical Plate System (K231593)Spinal Elements, Inc.2023-08-02
CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System (K231839)L&K BIOMED Co., Ltd.2023-07-19
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System (K231460)K&J Consulting Corp.2023-07-16
CODA™ Anterior Cervical Plate System (K230993)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech2023-06-20
Zevo Anterior Cervical Plate System (K231090)Medtronic Sofamor Danek USA, Inc.2023-06-15
Axis Anterior Cervical Plate System (K231145)Southern Medical (Pty) , Ltd.2023-06-13
ATEC Lateral Plate System (K230721)Alphatec Spine, Inc.2023-05-09
Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate System (K230424)Omnia Medical, LLC2023-04-12
Cervical Plate System (K223753)Double Medical Technology, Inc.2023-03-14
Omnia Medical Coupler-C Anterior Cervical Plate (K223321)Omnia Medical, LLC2023-03-13
Athena III Cervical Plate System (K230301)Medyssey USA, Inc.2023-03-07
Magnes-C Anterior Cervical Plate System (K221053)Fellowship of Orthopaedic Researchers, Inc.2023-03-01
PreView-III™ Anterior Cervical Plate System (K223627)Nexus Spine, LLC2023-02-02
Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System (K223719)Aegis Spine, Inc.2023-01-11
OAKTREE Anterior Lumbar Plate and Screw System (K220843)Oak Tree Engineering, LLC2022-12-07
CODA™ Anterior Cervical Plate System (K222493)Pioneer Surgical Technology, Inc.2022-11-18
Life Spine ALIF Buttress Plate System (K222628)Life Spine, Inc.2022-11-16
MONET Anterior Cervical Plate System (K220334)Ctl Medical Corporation2022-11-09
Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate (K221728)Stryker Corporation2022-10-19
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System (K222572)Dio Medical Corporation2022-10-18
CYGNUS™ MoRe Anterior Cervical Plate System (K220441)MiRus, LLC2022-09-16
VyPlate Anterior Cervical Plate System (K221572)Vy Spine, LLC2022-07-26
Venus Cervical Plate System (K211718)Artfx Medical, LLC2022-06-28
Cervical Spine Truss System Plating Solution (CSTS-PS) (K212527)4Web Medical, Inc.2022-05-17
Aggeris™-C (K220182)Clariance2022-03-30
BALTEUM - ONE™ Lumbar Plate System (K213820)Huvexel Co. , Ltd.2022-03-25
EMERGE Anterior Cervical Plate System (K220275)Evolution Spine2022-03-18
AccuFit Lateral 2-Hole Plate (K220324)Precision Spine, Inc.2022-03-16
IMPEACE and IMPEACE-Uni Anterior Cervical Plate System (K220379)Medynus, Inc.2022-03-03
Aspiron S ACP System (K220147)U&I Corporation2022-02-16
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 (K211712)Orthofix US, LLC2022-02-11
Cyclops™ Anterior Cervical Plate System (K213901)Degen Medical2022-01-07
Vy Spine™ VyWasher™ Buttress System (K213219)Vy Spine, LLC2021-12-23
Xenco Medical Multilevel CerviKit (K213456)Xenco Medical, LLC2021-12-21
Insignia™ Anterior Cervical Plate System (K213443)Alphatec Spine, Inc.2021-12-15
Dakota ALIF Plate System (K212937)Precision Spine, Inc.2021-11-04
NuVasive Anterior Cervical Plate Systems (K212446)Nu Vasive, Incorporated2021-11-03
Quantum Anterior Cervical Plate (K210424)Nvision Biomedical Technologies, Inc.2021-10-22
EMERGE™ Anterior Cervical Plate System (K212405)Evolution Spine2021-09-30
Admiral ACP System (K212139)SeaSpine Orthopedics Corporation2021-09-01
Shoreline Threaded TruProfile® Plate (K211903)SeaSpine Orthopedics Corporation2021-08-30
Prase-C Anterior Cervical Plate System (K211205)Gbs Commonwealth Co., Ltd.2021-08-12
Fixxsure Anterior Lumbar Plate and Screw System (K211932)Oak Tree Engineering, LLC2021-07-27
CervAlign® Anterior Cervical Plate System (K211408)Pioneer Surgical Technology, Inc.2021-06-23
PANAMA™ Anterior Cervical Plate (ACP) System (K210182)Flospine2021-04-07
APOLLO Anterior Cervical Plate (ACP) System (K210325)Aurora Spine, Inc.2021-03-23
Cure 2.0 Anterior Cervical Plate (ACP) System (K210286)Meditech Spine, LLC2021-03-18
Lumbar Spine Truss System Plating Solution (LSTS-PS) (K203065)4Web, Inc.2021-03-10
Prase-AP Anterior Cervical Plate System (K202878)Gbs Commonwealth Co., Ltd.2021-01-29
NuVasive ACP System (K203253)Nu Vasive, Incorporated2020-12-03
Anterior Cervical Plate System (K202972)Nutech Spine and Biologics2020-11-24
KASILOF Cervical Plate System (K203154)Kahtnu Surgical, Inc.2020-11-05
Z-Span Plate System (K202624)Zavation Medical Products, LLC2020-11-04
icotec Anterior Cervical Plate System (K201587)Icotec AG2020-10-15
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 (K202309)Zimmer Biomet Spine, Inc.2020-10-08
STRUXXURE®-L and STRUXXURE®-A Plate System (K202192)Nexxt Spine, LLC2020-09-17
Artus™ cervical plate system (K202227)Ulrich GmbH & Co. KG2020-09-14
Admiral ACP System (K202064)SeaSpine Orthopedics Corporation2020-08-26
Cervical Plate System (K201979)Eminent Spine, LLC2020-08-25
Medina Anterior Cervical Plate System (K201521)Alliance Partners, LLC2020-08-06
Aurora® Anterior Lumbar Plate Sytstem (K201079)Prism Surgical Design Pty , Ltd.2020-08-05
AccelFix Lumbar Plate System (K192481)L&K BIOMED Co., Ltd.2020-07-28
Transept Cervical Plate System (K200927)Neurostructures, Inc.2020-07-24
Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System (K201029)Spinal Elements, Inc.2020-06-17
CarboClear® Cervical Plate System (K200883)CarboFix Orthopedics , Ltd.2020-06-04
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