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FDA 510(k)

Dakota ALIF Plate System

K-Number: K212937 · 2021-11-04

ApplicantPrecision Spine, Inc.
Decision Date2021-11-04
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Dakota ALIF Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Precision Spine, Inc.. It received FDA 510(k) clearance on 2021-11-04 under 510(k) number K212937. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dakota ALIF Plate System?

Dakota ALIF Plate System is a medical device that received FDA 510(k) clearance on 2021-11-04. The listed applicant is Precision Spine, Inc.. The 510(k) number is K212937.

When did Dakota ALIF Plate System receive FDA 510(k) clearance?

Dakota ALIF Plate System received FDA 510(k) clearance on 2021-11-04, under 510(k) number K212937.

Who is the listed applicant for Dakota ALIF Plate System?

The FDA 510(k) record lists Precision Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dakota ALIF Plate System?

The FDA product code for Dakota ALIF Plate System is KWQ.

Other records listing Precision Spine, Inc. as applicant

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Related Devices (Code: KWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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