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FDA 510(k)

Ortholock Anchorage Devices

K-Number: K202691 · 2022-04-28

ApplicantCraniofacial Technologies, Inc.
Decision Date2022-04-28
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Ortholock Anchorage Devices is a medical device manufactured by Craniofacial Technologies, Inc.. It received FDA 510(k) clearance on 2022-04-28 under approval number K202691. 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 Ortholock Anchorage Devices?

Ortholock Anchorage Devices is a medical device that received FDA 510(k) clearance on 2022-04-28. It is manufactured by Craniofacial Technologies, Inc.. The 510(k) number is K202691.

When was Ortholock Anchorage Devices approved by the FDA?

Ortholock Anchorage Devices received FDA 510(k) clearance on 2022-04-28, under approval number K202691.

What company makes Ortholock Anchorage Devices?

Ortholock Anchorage Devices is manufactured by Craniofacial Technologies, Inc..

What is the FDA product code for Ortholock Anchorage Devices?

The FDA product code for Ortholock Anchorage Devices 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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