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FDA 510(k)

ATOZ Mini-Screw

K-Number: K210559 · 2021-12-19

ApplicantMk Meditech, Inc.
Decision Date2021-12-19
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ATOZ Mini-Screw is a medical device manufactured by Mk Meditech, Inc.. It received FDA 510(k) clearance on 2021-12-19 under approval number K210559. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATOZ Mini-Screw?

ATOZ Mini-Screw is a medical device that received FDA 510(k) clearance on 2021-12-19. It is manufactured by Mk Meditech, Inc.. The 510(k) number is K210559.

When was ATOZ Mini-Screw approved by the FDA?

ATOZ Mini-Screw received FDA 510(k) clearance on 2021-12-19, under approval number K210559.

What company makes ATOZ Mini-Screw?

ATOZ Mini-Screw is manufactured by Mk Meditech, Inc..

What is the FDA product code for ATOZ Mini-Screw?

The FDA product code for ATOZ Mini-Screw is OAT.

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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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