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FDA 510(k)

LOSPA II Knee System

K-Number: K192507 · 2019-12-11

Decision Date2019-12-11
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LOSPA II Knee System is a medical device manufactured by Corentec Co., Ltd.. It received FDA 510(k) clearance on 2019-12-11 under approval number K192507. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOSPA II Knee System?

LOSPA II Knee System is a medical device that received FDA 510(k) clearance on 2019-12-11. It is manufactured by Corentec Co., Ltd.. The 510(k) number is K192507.

When was LOSPA II Knee System approved by the FDA?

LOSPA II Knee System received FDA 510(k) clearance on 2019-12-11, under approval number K192507.

What company makes LOSPA II Knee System?

LOSPA II Knee System is manufactured by Corentec Co., Ltd..

What is the FDA product code for LOSPA II Knee System?

The FDA product code for LOSPA II Knee System is JWH.

Other Devices by Corentec Co., Ltd.

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Related Devices (Code: JWH)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.