量身定製-H 頸部獨立系統
K 號：K222903 · 2022-11-18
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器材摘要
Tailored-H Cervical Stand Alone System is the device name listed in this FDA 510(k) record. The listed applicant is Bespoke Technologies, LLC. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K222903. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Tailored-H Cervical Stand Alone System?
Tailored-H Cervical Stand Alone System is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Bespoke Technologies, LLC. The 510(k) number is K222903.
When did Tailored-H Cervical Stand Alone System receive FDA 510(k) clearance?
Tailored-H Cervical Stand Alone System received FDA 510(k) clearance on 2022-11-18, under 510(k) number K222903.
Who is the listed applicant for Tailored-H Cervical Stand Alone System?
The FDA 510(k) record lists Bespoke Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tailored-H Cervical Stand Alone System?
The FDA product code for Tailored-H Cervical Stand Alone System is OVE.
相關臨床試驗
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相關器械（代碼：OVE）
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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