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FDA 510(k)

LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation

K-Number: K222278 · 2022-08-26

ApplicantCorentec Co., Ltd.
Decision Date2022-08-26
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation is a medical device manufactured by Corentec Co., Ltd.. It received FDA 510(k) clearance on 2022-08-26 under approval number K222278. 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 TKR System Instrumentation, EXULT TKR System Instrumentation?

LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation is a medical device that received FDA 510(k) clearance on 2022-08-26. It is manufactured by Corentec Co., Ltd.. The 510(k) number is K222278.

When was LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation approved by the FDA?

LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation received FDA 510(k) clearance on 2022-08-26, under approval number K222278.

What company makes LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation?

LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation is manufactured by Corentec Co., Ltd..

What is the FDA product code for LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation?

The FDA product code for LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation is JWH.

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Official Source

View on FDA Database →

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

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