FDA 510(k)

OIC FLEX-FIX™ 系統

K 號：K233531 · 2024-02-02

決定日期2024-02-02

產品代碼HTN

諮詢委員會或

決定相當於

器材摘要

OIC FLEX-FIX™ System is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic Implant Company. It received FDA 510(k) clearance on 2024-02-02 under 510(k) number K233531. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OIC FLEX-FIX™ System?

OIC FLEX-FIX™ System is a medical device that received FDA 510(k) clearance on 2024-02-02. The listed applicant is Orthopaedic Implant Company. The 510(k) number is K233531.

When did OIC FLEX-FIX™ System receive FDA 510(k) clearance?

OIC FLEX-FIX™ System received FDA 510(k) clearance on 2024-02-02, under 510(k) number K233531.

Who is the listed applicant for OIC FLEX-FIX™ System?

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

What is the FDA product code for OIC FLEX-FIX™ System?

The FDA product code for OIC FLEX-FIX™ System is HTN.

其他以 Orthopaedic Implant Company 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。

K223761OIC 髓內釘系統 K223118OIC可調角度小型骨折固定板系統 K212601DRPx 遠端桡骨固定板系統 K202971DRPx 遠端桡骨固定板系統 K211112OIC外固定系統 K183682OIC外固定系統

查看所有 8 項裝置 →

相關器械（代碼：HTN）

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。

K253115LARS ACJMovmedix S.A.S.K252081運動連結關節固定器Lincotek Medical K253727關節固定緊繩PROArthrex, Inc.K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)K251134RipCordTriMed, Inc.K243624Acu-Sinch Knotless MiniAcumed, LLC

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。