FDA 510(k)

GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER

K-Number: K052639 · 2006-05-03

Decision Date2006-05-03

Product CodeJDI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing, Inc.. It received FDA 510(k) clearance on 2006-05-03 under 510(k) number K052639. 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 GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER?

GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER is a medical device that received FDA 510(k) clearance on 2006-05-03. The listed applicant is Biomet Manufacturing, Inc.. The 510(k) number is K052639.

When did GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER receive FDA 510(k) clearance?

GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER received FDA 510(k) clearance on 2006-05-03, under 510(k) number K052639.

Who is the listed applicant for GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER?

The FDA 510(k) record lists Biomet Manufacturing, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER?

The FDA product code for GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER is JDI.

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Official Source

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