LOSPA TKR System
K-Number: K212034 · 2021-12-09
ApplicantCorentec Co., Ltd.
Decision Date2021-12-09
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
LOSPA TKR System is a medical device manufactured by Corentec Co., Ltd.. It received FDA 510(k) clearance on 2021-12-09 under approval number K212034. 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?
LOSPA TKR System is a medical device that received FDA 510(k) clearance on 2021-12-09. It is manufactured by Corentec Co., Ltd.. The 510(k) number is K212034.
When was LOSPA TKR System approved by the FDA?
LOSPA TKR System received FDA 510(k) clearance on 2021-12-09, under approval number K212034.
What company makes LOSPA TKR System?
LOSPA TKR System is manufactured by Corentec Co., Ltd..
What is the FDA product code for LOSPA TKR System?
The FDA product code for LOSPA TKR System 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.