SOLACE 骨盆釘定系統
K 號：K233241 · 2023-10-27
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器材摘要
SOLACE Sacroiliac Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Ht Medical, LLC Dba Xenix Medical. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K233241. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SOLACE Sacroiliac Fixation System?
SOLACE Sacroiliac Fixation System is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is Ht Medical, LLC Dba Xenix Medical. The 510(k) number is K233241.
When did SOLACE Sacroiliac Fixation System receive FDA 510(k) clearance?
SOLACE Sacroiliac Fixation System received FDA 510(k) clearance on 2023-10-27, under 510(k) number K233241.
Who is the listed applicant for SOLACE Sacroiliac Fixation System?
The FDA 510(k) record lists Ht Medical, LLC Dba Xenix Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SOLACE Sacroiliac Fixation System?
The FDA product code for SOLACE Sacroiliac Fixation System is OUR.
相關臨床試驗
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相關器械（代碼：OUR）
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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