FDA 510(k)

ATEC Alignment App

K-Number: K211987 · 2021-10-29

Decision Date2021-10-29

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ATEC Alignment App is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2021-10-29 under approval number K211987. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATEC Alignment App?

ATEC Alignment App is a medical device that received FDA 510(k) clearance on 2021-10-29. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K211987.

When was ATEC Alignment App approved by the FDA?

ATEC Alignment App received FDA 510(k) clearance on 2021-10-29, under approval number K211987.

What company makes ATEC Alignment App?

ATEC Alignment App is manufactured by Alphatec Spine, Inc..

What is the FDA product code for ATEC Alignment App?

The FDA product code for ATEC Alignment App is LLZ.

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Official Source

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