FDA 510(k)PILLAR SA PTC
K 號:K161129 · 2016-09-08
決定日期2016-09-08
產品代碼OVD
諮詢委員會OR
決定Substantially Equivalent
器材摘要
PILLAR SA PTC is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix, Inc.. It received FDA 510(k) clearance on 2016-09-08 under 510(k) number K161129. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the PILLAR SA PTC?
PILLAR SA PTC is a medical device that received FDA 510(k) clearance on 2016-09-08. The listed applicant is Orthofix, Inc.. The 510(k) number is K161129.
When did PILLAR SA PTC receive FDA 510(k) clearance?
PILLAR SA PTC received FDA 510(k) clearance on 2016-09-08, under 510(k) number K161129.
Who is the listed applicant for PILLAR SA PTC?
The FDA 510(k) record lists Orthofix, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PILLAR SA PTC?
The FDA product code for PILLAR SA PTC is OVD.
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其他以 Orthofix, 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。
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相關器械(代碼:OVD)
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。