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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 the device name listed in this FDA 510(k) record. The listed applicant is Craniofacial Technologies, Inc.. It received FDA 510(k) clearance on 2022-04-28 under 510(k) 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. The listed applicant is Craniofacial Technologies, Inc.. The 510(k) number is K202691.

When did Ortholock Anchorage Devices receive FDA 510(k) clearance?

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

Who is the listed applicant for Ortholock Anchorage Devices?

The FDA 510(k) record lists Craniofacial Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ortholock Anchorage Devices?

The FDA product code for Ortholock Anchorage Devices is OAT.

Related Devices (Code: OAT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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