FDA 510(k)

MOBIO全膝系統後穩定（PS和PS+）胫骨插板，MOBIO全膝系統髌骨組件

K 號：K183025 · 2019-01-28

決定日期2019-01-28

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component is the device name listed in this FDA 510(k) record. The listed applicant is B-One Ortho, Corp.. It received FDA 510(k) clearance on 2019-01-28 under 510(k) number K183025. 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 MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component?

MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component is a medical device that received FDA 510(k) clearance on 2019-01-28. The listed applicant is B-One Ortho, Corp.. The 510(k) number is K183025.

When did MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component receive FDA 510(k) clearance?

MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component received FDA 510(k) clearance on 2019-01-28, under 510(k) number K183025.

Who is the listed applicant for MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component?

FDA 510(k) 記錄將 B-One Ortho, Corp. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component?

The FDA product code for MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component is JWH.