正位鎖定固定器
K 號：K202691 · 2022-04-28
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器材摘要
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.
常見問題
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.
相關臨床試驗
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相關器械（代碼：OAT）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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