C-Stem AMT LE Prosthesis
K-Number: K220216 · 2022-07-22
ApplicantDepuy Ireland UC
Decision Date2022-07-22
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
C-Stem AMT LE Prosthesis is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2022-07-22 under approval number K220216. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the C-Stem AMT LE Prosthesis?
C-Stem AMT LE Prosthesis is a medical device that received FDA 510(k) clearance on 2022-07-22. It is manufactured by Depuy Ireland UC. The 510(k) number is K220216.
When was C-Stem AMT LE Prosthesis approved by the FDA?
C-Stem AMT LE Prosthesis received FDA 510(k) clearance on 2022-07-22, under approval number K220216.
What company makes C-Stem AMT LE Prosthesis?
C-Stem AMT LE Prosthesis is manufactured by Depuy Ireland UC.
What is the FDA product code for C-Stem AMT LE Prosthesis?
The FDA product code for C-Stem AMT LE Prosthesis is JDI.
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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.