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FDA 510(k)

ATEC Lateral Plate System

K-Number: K230721 · 2023-05-09

Decision Date2023-05-09
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ATEC Lateral Plate System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2023-05-09 under approval number K230721. 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 ATEC Lateral Plate System?

ATEC Lateral Plate System is a medical device that received FDA 510(k) clearance on 2023-05-09. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K230721.

When was ATEC Lateral Plate System approved by the FDA?

ATEC Lateral Plate System received FDA 510(k) clearance on 2023-05-09, under approval number K230721.

What company makes ATEC Lateral Plate System?

ATEC Lateral Plate System is manufactured by Alphatec Spine, Inc..

What is the FDA product code for ATEC Lateral Plate System?

The FDA product code for ATEC Lateral Plate System is KWQ.

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Official Source

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