FDA 510(k)

Dakota ALIF System

K-Number: K213118 · 2022-04-01

Decision Date2022-04-01

Product CodeOVD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Dakota ALIF System is a medical device manufactured by Precision Spine, Inc.. It received FDA 510(k) clearance on 2022-04-01 under approval number K213118. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dakota ALIF System?

Dakota ALIF System is a medical device that received FDA 510(k) clearance on 2022-04-01. It is manufactured by Precision Spine, Inc.. The 510(k) number is K213118.

When was Dakota ALIF System approved by the FDA?

Dakota ALIF System received FDA 510(k) clearance on 2022-04-01, under approval number K213118.

What company makes Dakota ALIF System?

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

What is the FDA product code for Dakota ALIF System?

The FDA product code for Dakota ALIF System is OVD.

Other Devices by Precision Spine, Inc.

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Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, 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.