FDA 510(k)

PS2 過膝系統

K 號：K160515 · 2016-12-19

決定日期2016-12-19

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

PS2 Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Consensus Orthopedics, Inc.. It received FDA 510(k) clearance on 2016-12-19 under 510(k) number K160515. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PS2 Knee System?

PS2 Knee System is a medical device that received FDA 510(k) clearance on 2016-12-19. The listed applicant is Consensus Orthopedics, Inc.. The 510(k) number is K160515.

When did PS2 Knee System receive FDA 510(k) clearance?

PS2 Knee System received FDA 510(k) clearance on 2016-12-19, under 510(k) number K160515.

Who is the listed applicant for PS2 Knee System?

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

What is the FDA product code for PS2 Knee System?

The FDA product code for PS2 Knee System is JWH.

其他以 Consensus Orthopedics, Inc. 為申請人之記錄

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K170344塔霍聯合膝關節系統 K163167CKS Plus 適合膝關節系統

相關器械（代碼：JWH）

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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官方來源

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