Appliance, Fixation, Spinal Intervertebral Body

FDA product code KWQ · 626 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3060
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1979-03-21 – 2026-09-24

KWQ 2026-09-24

corra® cervical plating system

Applicant Carlsmed, Inc.

K number K262149

View details →

KWQ 2026-07-16

Palisades™ Buttress Plate System

Applicant Bethesda Medical Devices, LLC

K number K261309

View details →

KWQ 2026-05-14

ARIES Anterior Cervical Plate Systems

Applicant ZheJiang Decans Medical Devices Co., Ltd.

K number K252776

View details →

KWQ 2026-05-06

CastleLoc-P Anterior Cervical Plate System

Applicant L&K BIOMED Co., Ltd.

K number K261112

View details →

KWQ 2026-04-22

corra™ cervical plating system

Applicant Carlsmed, Inc.

K number K260570

View details →

KWQ 2026-03-27

VyPlate™ Anterior Cervical Plate System

Applicant Vy Spine, LLC

K number K260697

View details →

KWQ 2026-03-04

ANTERIS Thoracolumbar Plate System

Applicant SpineCraft

K number K260015

View details →

KWQ 2026-03-03

PathLoc Lumbar Plate System

Applicant L&K BIOMED Co., Ltd.

K number K251940

View details →

KWQ 2026-02-26

Aster

Applicant Osteonic Co., Ltd.

K number K254182

View details →

KWQ 2026-02-12

Lumbar Spine Truss System - Plating Solution (LSTS-PS)

Applicant 4Web, Inc.

K number K253201

View details →

KWQ 2025-12-22

aprevo® cervical plating system

Applicant Carlsmed, Inc.

K number K252611

View details →

KWQ 2025-08-28

Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)

Applicant Alphatec Spine, Inc.

K number K251965

View details →

KWQ 2025-07-11

Resolve Anterior Cervical Plate System

Applicant Pioneer Surgical Technology, Inc.

K number K251436

View details →

KWQ 2025-05-23

Frida™ Anterior Cervical Plate System

Applicant Spineup, Inc.

K number K250446

View details →

KWQ 2025-05-20

X-PAC® N-GAGE™ Lumbar Plate System

Applicant Expanding Innovations, Inc.

K number K250602

View details →

KWQ 2025-04-10

Skyway Anterior Cervical Plate System

Applicant Kyocera Medical Technologies Inc. (KMTI)

K number K250486

View details →

KWQ 2025-01-14

Elegance® Anterior Cervical plate

Applicant Clariance

K number K243904

View details →

KWQ 2024-12-11

Cervical Plating System

Applicant Life Spine, Inc.

K number K243369

View details →

KWQ 2024-11-07

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

Applicant Stryker Spine

K number K242361

View details →

KWQ 2024-11-05

Skyway Anterior Cervical Plate System

Applicant Kyocera Medical Technologies, Inc.

K number K243015

View details →

KWQ 2024-07-24

FlexWing Anterior Cervical Plate System

Applicant Jeil Medical Corporation

K number K231251

View details →

KWQ 2024-05-24

Wolff's Law Anterior Cervical Plate System

Applicant Spinal Simplicity, LLC

K number K240592

View details →

KWQ 2024-05-17

MiRus MoRe Lumbar Plating System

Applicant MiRus, LLC

K number K241175

View details →

KWQ 2024-05-17

ARENAL Anterior Cervical Plate System

Applicant Effortmed, LLC

K number K240935

View details →

KWQ 2024-05-17

icotec Anterior Cervical Plate System

Applicant Icotec AG

K number K233215

View details →

KWQ 2024-04-17

MSFX Mikron Cervical Anterior Plate System

Applicant Mikron Makina Sanayi VE Ticaret Ltd. Sti.

K number K240484

View details →

KWQ 2024-04-16

Alcantara Thoracolumbar Plate System

Applicant Camber Spine Technologies, LLC

K number K232256

View details →

KWQ 2024-04-08

TDM Anterior Cervical Plate System

Applicant Tdm Co., Ltd.

K number K240423

View details →

KWQ 2024-03-22

STRUXXURE® MCS Anterior Cervical Plate System

Applicant Nexxt Spine

K number K240690

View details →

KWQ 2024-03-18

uNion® MAX Cervical Plate System

Applicant Ulrich Medical USA, Inc.

K number K240515

View details →

KWQ 2024-02-29

Curiteva Thoracolumbar Plate System

Applicant Curiteva, Inc.

K number K233360

View details →

KWQ 2024-02-22

Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System

Applicant Alphatec Spine, Inc.

K number K233640

View details →

KWQ 2024-01-26

MONDRIAN™ Anterior Lumbar Plate System

Applicant Ctl Medical Corporation

K number K231715

View details →

KWQ 2024-01-25

ADIRA™ Lateral Plate System

Applicant Globus Medical, Inc.

K number K233735

View details →

KWQ 2023-10-31

VICTORY™ Lumbar Plate System

Applicant Globus Medical, Inc.

K number K232318

View details →

KWQ 2023-09-12

Skyway Anterior Cervical Plate System

Applicant Kyocera Medical Technologies Inc. (KMTI)

K number K231766

View details →

KWQ 2023-08-02

Sapphire X3 Anterior Cervical Plate System

Applicant Spinal Elements, Inc.

K number K231593

View details →

KWQ 2023-07-19

CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System

Applicant L&K BIOMED Co., Ltd.

K number K231839

View details →

KWQ 2023-07-16

FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System

Applicant K&J Consulting Corp.

K number K231460

View details →

KWQ 2023-06-20

CODA™ Anterior Cervical Plate System

Applicant Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech

K number K230993

View details →

KWQ 2023-06-15

Zevo Anterior Cervical Plate System

Applicant Medtronic Sofamor Danek USA, Inc.

K number K231090

View details →

KWQ 2023-06-13

Axis Anterior Cervical Plate System

Applicant Southern Medical (Pty) , Ltd.

K number K231145

View details →

KWQ 2023-05-09

ATEC Lateral Plate System

Applicant Alphatec Spine, Inc.

K number K230721

View details →

KWQ 2023-04-12

Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate System

Applicant Omnia Medical, LLC

K number K230424

View details →

KWQ 2023-03-14

Cervical Plate System

Applicant Double Medical Technology, Inc.

K number K223753

View details →

KWQ 2023-03-13

Omnia Medical Coupler-C Anterior Cervical Plate

Applicant Omnia Medical, LLC

K number K223321

View details →

KWQ 2023-03-07

Athena III Cervical Plate System

Applicant Medyssey USA, Inc.

K number K230301

View details →

KWQ 2023-03-01

Magnes-C Anterior Cervical Plate System

Applicant Fellowship of Orthopaedic Researchers, Inc.

K number K221053

View details →

KWQ 2023-02-02

PreView-III™ Anterior Cervical Plate System

Applicant Nexus Spine, LLC

K number K223627

View details →

KWQ 2023-01-11

Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System

Applicant Aegis Spine, Inc.

K number K223719

View details →

KWQ 2022-12-07

OAKTREE Anterior Lumbar Plate and Screw System

Applicant Oak Tree Engineering, LLC

K number K220843

View details →

KWQ 2022-11-18

CODA™ Anterior Cervical Plate System

Applicant Pioneer Surgical Technology, Inc.

K number K222493

View details →

KWQ 2022-11-16

Life Spine ALIF Buttress Plate System

Applicant Life Spine, Inc.

K number K222628

View details →

KWQ 2022-11-09

MONET Anterior Cervical Plate System

Applicant Ctl Medical Corporation

K number K220334

View details →

KWQ 2022-10-19

Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate

Applicant Stryker Corporation

K number K221728

View details →

KWQ 2022-10-18

FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System

Applicant Dio Medical Corporation

K number K222572

View details →

KWQ 2022-09-16

CYGNUS™ MoRe Anterior Cervical Plate System

Applicant MiRus, LLC

K number K220441

View details →

KWQ 2022-07-26

VyPlate Anterior Cervical Plate System

Applicant Vy Spine, LLC

K number K221572

View details →

KWQ 2022-06-28

Venus Cervical Plate System

Applicant Artfx Medical, LLC

K number K211718

View details →

KWQ 2022-05-17

Cervical Spine Truss System Plating Solution (CSTS-PS)

Applicant 4Web Medical, Inc.

K number K212527

View details →

KWQ 2022-03-30

Aggeris™-C

Applicant Clariance

K number K220182

View details →

KWQ 2022-03-25

BALTEUM - ONE™ Lumbar Plate System

Applicant Huvexel Co. , Ltd.

K number K213820

View details →

KWQ 2022-03-18

EMERGE Anterior Cervical Plate System

Applicant Evolution Spine

K number K220275

View details →

KWQ 2022-03-16

AccuFit Lateral 2-Hole Plate

Applicant Precision Spine, Inc.

K number K220324

View details →

KWQ 2022-03-03

IMPEACE and IMPEACE-Uni Anterior Cervical Plate System

Applicant Medynus, Inc.

K number K220379

View details →

KWQ 2022-02-16

Aspiron S ACP System

Applicant U&I Corporation

K number K220147

View details →

KWQ 2022-02-11

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

Applicant Orthofix US, LLC

K number K211712

View details →

KWQ 2022-01-07

Cyclops™ Anterior Cervical Plate System

Applicant Degen Medical

K number K213901

View details →

KWQ 2021-12-23

Vy Spine™ VyWasher™ Buttress System

Applicant Vy Spine, LLC

K number K213219

View details →

KWQ 2021-12-21

Xenco Medical Multilevel CerviKit

Applicant Xenco Medical, LLC

K number K213456

View details →

KWQ 2021-12-15

Insignia™ Anterior Cervical Plate System

Applicant Alphatec Spine, Inc.

K number K213443

View details →

KWQ 2021-11-04

Dakota ALIF Plate System

Applicant Precision Spine, Inc.

K number K212937

View details →

KWQ 2021-11-03

NuVasive Anterior Cervical Plate Systems

Applicant Nu Vasive, Incorporated

K number K212446

View details →

KWQ 2021-10-22

Quantum Anterior Cervical Plate

Applicant Nvision Biomedical Technologies, Inc.

K number K210424

View details →

KWQ 2021-09-30

EMERGE™ Anterior Cervical Plate System

Applicant Evolution Spine

K number K212405

View details →

KWQ 2021-09-01

Admiral ACP System

Applicant SeaSpine Orthopedics Corporation

K number K212139

View details →

KWQ 2021-08-30

Shoreline Threaded TruProfile® Plate

Applicant SeaSpine Orthopedics Corporation

K number K211903

View details →

KWQ 2021-08-12

Prase-C Anterior Cervical Plate System

Applicant Gbs Commonwealth Co., Ltd.

K number K211205

View details →

KWQ 2021-07-27

Fixxsure Anterior Lumbar Plate and Screw System

Applicant Oak Tree Engineering, LLC

K number K211932

View details →

KWQ 2021-06-23

CervAlign® Anterior Cervical Plate System

Applicant Pioneer Surgical Technology, Inc.

K number K211408

View details →

KWQ 2021-04-07

PANAMA™ Anterior Cervical Plate (ACP) System

Applicant Flospine

K number K210182

View details →

KWQ 2021-03-23

APOLLO Anterior Cervical Plate (ACP) System

Applicant Aurora Spine, Inc.

K number K210325

View details →

KWQ 2021-03-18

Cure 2.0 Anterior Cervical Plate (ACP) System

Applicant Meditech Spine, LLC

K number K210286

View details →

KWQ 2021-03-10

Lumbar Spine Truss System Plating Solution (LSTS-PS)

Applicant 4Web, Inc.

K number K203065

View details →

KWQ 2021-01-29

Prase-AP Anterior Cervical Plate System

Applicant Gbs Commonwealth Co., Ltd.

K number K202878

View details →

KWQ 2020-12-03

NuVasive ACP System

Applicant Nu Vasive, Incorporated

K number K203253

View details →

KWQ 2020-11-24

Anterior Cervical Plate System

Applicant Nutech Spine and Biologics

K number K202972

View details →

KWQ 2020-11-05

KASILOF Cervical Plate System

Applicant Kahtnu Surgical, Inc.

K number K203154

View details →

KWQ 2020-11-04

Z-Span Plate System

Applicant Zavation Medical Products, LLC

K number K202624

View details →

KWQ 2020-10-15

icotec Anterior Cervical Plate System

Applicant Icotec AG

K number K201587

View details →

KWQ 2020-10-08

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

Applicant Zimmer Biomet Spine, Inc.

K number K202309

View details →

KWQ 2020-09-17

STRUXXURE®-L and STRUXXURE®-A Plate System

Applicant Nexxt Spine, LLC

K number K202192

View details →

KWQ 2020-09-14

Artus™ cervical plate system

Applicant Ulrich GmbH & Co. KG

K number K202227

View details →

KWQ 2020-08-26

Admiral ACP System

Applicant SeaSpine Orthopedics Corporation

K number K202064

View details →

KWQ 2020-08-25

Cervical Plate System

Applicant Eminent Spine, LLC

K number K201979

View details →

KWQ 2020-08-06

Medina Anterior Cervical Plate System

Applicant Alliance Partners, LLC

K number K201521

View details →

KWQ 2020-08-05

Aurora® Anterior Lumbar Plate Sytstem

Applicant Prism Surgical Design Pty , Ltd.

K number K201079

View details →

KWQ 2020-07-28

AccelFix Lumbar Plate System

Applicant L&K BIOMED Co., Ltd.

K number K192481

View details →

KWQ 2020-07-24

Transept Cervical Plate System

Applicant Neurostructures, Inc.

K number K200927

View details →

KWQ 2020-06-17

Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System

Applicant Spinal Elements, Inc.

K number K201029

View details →