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510(k) K212937

Device
Dakota ALIF Plate System
Applicant
Precision Spine, Inc.
510(k) number
K212937
Product code
KWQ  
Decision
Substantially Equivalent (SESE)
Decision date
2021-11-04
Date received
2021-09-15
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
No

Applicant Contact#

Contact
Michael Dawson
Address
2050 Executive Dr.. Pear MS US 39208 39208

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KWQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC2026-07-16
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

Legacy Summary#

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FDA Review#

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