FDA 510(k)

OIC縫合釘系統

K 號：K182736 · 2018-12-28

決定日期2018-12-28

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

OIC Suture Anchor System is the device name listed in this FDA 510(k) record. The listed applicant is The Orthopaedic Implant Company. It received FDA 510(k) clearance on 2018-12-28 under 510(k) number K182736. 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 OIC Suture Anchor System?

OIC Suture Anchor System is a medical device that received FDA 510(k) clearance on 2018-12-28. The listed applicant is The Orthopaedic Implant Company. The 510(k) number is K182736.

When did OIC Suture Anchor System receive FDA 510(k) clearance?

OIC Suture Anchor System received FDA 510(k) clearance on 2018-12-28, under 510(k) number K182736.

Who is the listed applicant for OIC Suture Anchor System?

The FDA 510(k) record lists The Orthopaedic Implant Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OIC Suture Anchor System?

The FDA product code for OIC Suture Anchor System is MBI.

其他以 The Orthopaedic Implant Company 為申請人之記錄

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