FDA 510(k)

Ortholock Anchorage Devices

Número K: K202691 · 2022-04-28

RequerenteCraniofacial Technologies, Inc.

Data da decisão2022-04-28

Código do produtoOAT

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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