K2M Growing Spine System
K 號：K161028 · 2016-07-22
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器材摘要
K2M Growing Spine System is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2016-07-22 under 510(k) number K161028. The device is classified under product code PGM. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the K2M Growing Spine System?
K2M Growing Spine System is a medical device that received FDA 510(k) clearance on 2016-07-22. The listed applicant is K2m, Inc.. The 510(k) number is K161028.
When did K2M Growing Spine System receive FDA 510(k) clearance?
K2M Growing Spine System received FDA 510(k) clearance on 2016-07-22, under 510(k) number K161028.
Who is the listed applicant for K2M Growing Spine System?
The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for K2M Growing Spine System?
The FDA product code for K2M Growing Spine System is PGM.
相關臨床試驗
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其他以 K2m, Inc. 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：PGM）
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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