Sphynx™
K 號：K160982 · 2016-12-22
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器材摘要
Sphynx™ is the device name listed in this FDA 510(k) record. The listed applicant is Eden Spine, LLC. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K160982. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Sphynx™?
Sphynx™ is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Eden Spine, LLC. The 510(k) number is K160982.
When did Sphynx™ receive FDA 510(k) clearance?
Sphynx™ received FDA 510(k) clearance on 2016-12-22, under 510(k) number K160982.
Who is the listed applicant for Sphynx™?
The FDA 510(k) record lists Eden Spine, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sphynx™?
The FDA product code for Sphynx™ is KWQ.
相關臨床試驗
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相關器械（代碼：KWQ）
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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