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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2022-07-22 under 510(k) 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. The listed applicant is Depuy Ireland UC. The 510(k) number is K220216.

When did C-Stem AMT LE Prosthesis receive FDA 510(k) clearance?

C-Stem AMT LE Prosthesis received FDA 510(k) clearance on 2022-07-22, under 510(k) number K220216.

Who is the listed applicant for C-Stem AMT LE Prosthesis?

The FDA 510(k) record lists Depuy Ireland UC as the applicant. This does not by itself establish the device manufacturer.

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.

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