FDA 510(k)

RejuvaKnee™ 膝蓋軟骨植入體

K 號：K242302 · 2024-10-02

決定日期2024-10-02

產品代碼OLC

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

RejuvaKnee™ Collagen Meniscus Implant is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2024-10-02 under 510(k) number K242302. The device is classified under product code OLC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RejuvaKnee™ Collagen Meniscus Implant?

RejuvaKnee™ Collagen Meniscus Implant is a medical device that received FDA 510(k) clearance on 2024-10-02. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K242302.

When did RejuvaKnee™ Collagen Meniscus Implant receive FDA 510(k) clearance?

RejuvaKnee™ Collagen Meniscus Implant received FDA 510(k) clearance on 2024-10-02, under 510(k) number K242302.

Who is the listed applicant for RejuvaKnee™ Collagen Meniscus Implant?

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

What is the FDA product code for RejuvaKnee™ Collagen Meniscus Implant?

The FDA product code for RejuvaKnee™ Collagen Meniscus Implant is OLC.

其他以 Collagen Matrix, 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。

K251191膠原蛋白杜拉再生薄膜 - 修復 K243071牛真皮膠原膚質基質 K233203軟組織增強可吸收網格 K240424礦物膠原蛋白複合生物活性可塑骨移植基质 K231942礦物膠原蛋白複合生物活性超可塑材 K221735礦物膠原蛋白複合生物活性可塑模具

查看所有 16 項裝置 →

相關器械（代碼：OLC）

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。

K170364膠原韌帶植入體XLIvy Sports Medicine, 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。