FDA.report

510(k) K251965

Device
Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)
Applicant
Alphatec Spine, Inc.
510(k) number
K251965
Product code
KWQ
Decision
Substantially Equivalent (SESE)
Decision date
2025-08-28
Date received
2025-06-26
Regulation
888.3060
Classification name
Appliance, Fixation, Spinal Intervertebral Body
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Griffin Riggs
Address
1950 Camino Vida Roble Carlsbad CA US 92008 92008

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00190376695310ProximityALPHATEC SPINE, INC.2025-12-19
00190376656847ProximityALPHATEC SPINE, INC.2025-12-19
00190376695174ProximityALPHATEC SPINE, INC.2025-12-19
00190376695181ProximityALPHATEC SPINE, INC.2025-12-19
00190376695198ProximityALPHATEC SPINE, INC.2025-12-19
00190376695204ProximityALPHATEC SPINE, INC.2025-12-19
00190376695211ProximityALPHATEC SPINE, INC.2025-12-19
00190376695228ProximityALPHATEC SPINE, INC.2025-12-19
00190376695235ProximityALPHATEC SPINE, INC.2025-12-19
00190376695242ProximityALPHATEC SPINE, INC.2025-12-19
00190376695259ProximityALPHATEC SPINE, INC.2025-12-19
00190376695266ProximityALPHATEC SPINE, INC.2025-12-19
00190376695273ProximityALPHATEC SPINE, INC.2025-12-19
00190376695280ProximityALPHATEC SPINE, INC.2025-12-19
00190376695297ProximityALPHATEC SPINE, INC.2025-12-19
00190376695303ProximityALPHATEC SPINE, INC.2025-12-19
00190376695464ProximityALPHATEC SPINE, INC.2025-12-19
00190376695327ProximityALPHATEC SPINE, INC.2025-12-19
00190376695334ProximityALPHATEC SPINE, INC.2025-12-19
00190376695341ProximityALPHATEC SPINE, INC.2025-12-19
00190376695358ProximityALPHATEC SPINE, INC.2025-12-19
00190376695365ProximityALPHATEC SPINE, INC.2025-12-19
00190376695372ProximityALPHATEC SPINE, INC.2025-12-19
00190376695389ProximityALPHATEC SPINE, INC.2025-12-19
00190376695396ProximityALPHATEC SPINE, INC.2025-12-19
00190376695402ProximityALPHATEC SPINE, INC.2025-12-19
00190376695419ProximityALPHATEC SPINE, INC.2025-12-19
00190376695426ProximityALPHATEC SPINE, INC.2025-12-19
00190376695433ProximityALPHATEC SPINE, INC.2025-12-19
00190376695440ProximityALPHATEC SPINE, INC.2025-12-19

Other 510(k) Records For Product Code KWQ

510(k)DeviceApplicantDecision date
K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.2026-05-14
K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.2026-05-06
K260570corra™ cervical plating systemCarlsmed, Inc.2026-04-22
K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC2026-03-27
K260015ANTERIS Thoracolumbar Plate SystemSpineCraft2026-03-04
K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.2026-03-03
K254182AsterOsteonic Co., Ltd.2026-02-26
K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.2026-02-12
K252611aprevo® cervical plating systemCarlsmed, Inc.2025-12-22
K251436Resolve Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.2025-07-11
K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.2025-05-23
K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.2025-05-20
K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)2025-04-10
K243904Elegance® Anterior Cervical plateClariance2025-01-14
K243369Cervical Plating SystemLife Spine, Inc.2024-12-11