FDA.report

510(k) K230721

Device
ATEC Lateral Plate System
Applicant
Alphatec Spine, Inc.
510(k) number
K230721
Product code
KWQ
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-09
Date received
2023-03-15
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
Aditya Aiyer
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
00190376525792Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376523620Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376523637Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376523651Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376523699Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376523705Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376523712Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376523729Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376525747Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376525754Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376525761Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376525778Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376525785Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376525914Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376525808Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376525815Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376525822Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376525839Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376525846Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376525853Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376525860Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376525877Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376525884Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376525891Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05
00190376525907Trauma Plate SystemALPHATEC SPINE, INC.2023-10-05

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
K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.2025-08-28
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