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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 a medical device manufactured by Precision Spine, Inc.. It received FDA 510(k) clearance on 2021-11-04 under approval 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. It is manufactured by Precision Spine, Inc.. The 510(k) number is K212937.

When was Dakota ALIF Plate System approved by the FDA?

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

What company makes Dakota ALIF Plate System?

Dakota ALIF Plate System is manufactured by Precision Spine, Inc..

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

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

Related Clinical Trials

NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Other Devices by Precision Spine, Inc.

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Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, Inc.

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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