REMEDY Stemmed Knee Spacer
K-Number: K223650 · 2023-01-05
ApplicantOsteoremedies, LLC
Decision Date2023-01-05
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
REMEDY Stemmed Knee Spacer is a medical device manufactured by Osteoremedies, LLC. It received FDA 510(k) clearance on 2023-01-05 under approval number K223650. 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 REMEDY Stemmed Knee Spacer?
REMEDY Stemmed Knee Spacer is a medical device that received FDA 510(k) clearance on 2023-01-05. It is manufactured by Osteoremedies, LLC. The 510(k) number is K223650.
When was REMEDY Stemmed Knee Spacer approved by the FDA?
REMEDY Stemmed Knee Spacer received FDA 510(k) clearance on 2023-01-05, under approval number K223650.
What company makes REMEDY Stemmed Knee Spacer?
REMEDY Stemmed Knee Spacer is manufactured by Osteoremedies, LLC.
What is the FDA product code for REMEDY Stemmed Knee Spacer?
The FDA product code for REMEDY Stemmed Knee Spacer 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.