ROSA Spine
K 號：K151511 · 2016-01-04
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器材摘要
ROSA Spine is the device name listed in this FDA 510(k) record. The listed applicant is Medtech S.A. It received FDA 510(k) clearance on 2016-01-04 under 510(k) number K151511. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ROSA Spine?
ROSA Spine is a medical device that received FDA 510(k) clearance on 2016-01-04. The listed applicant is Medtech S.A. The 510(k) number is K151511.
When did ROSA Spine receive FDA 510(k) clearance?
ROSA Spine received FDA 510(k) clearance on 2016-01-04, under 510(k) number K151511.
Who is the listed applicant for ROSA Spine?
The FDA 510(k) record lists Medtech S.A as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ROSA Spine?
The FDA product code for ROSA Spine is OLO.
相關臨床試驗
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其他以 Medtech S.A 為申請人之記錄
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。
相關器械（代碼：OLO）
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。
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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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