FDA 510(k)

骨維坊縫合釘

K 號：K190915 · 2019-07-03

決定日期2019-07-03

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

OsteoFab Suture Anchors is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Performance Materials, Inc.. It received FDA 510(k) clearance on 2019-07-03 under 510(k) number K190915. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OsteoFab Suture Anchors?

OsteoFab Suture Anchors is a medical device that received FDA 510(k) clearance on 2019-07-03. The listed applicant is Oxford Performance Materials, Inc.. The 510(k) number is K190915.

When did OsteoFab Suture Anchors receive FDA 510(k) clearance?

OsteoFab Suture Anchors received FDA 510(k) clearance on 2019-07-03, under 510(k) number K190915.

Who is the listed applicant for OsteoFab Suture Anchors?

The FDA 510(k) record lists Oxford Performance Materials, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OsteoFab Suture Anchors?

The FDA product code for OsteoFab Suture Anchors is MBI.

其他以 Oxford Performance Materials, Inc. 為申請人之記錄

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相關器械（代碼：MBI）

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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