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FDA 510(k)

PROFEMUR Z REVISION HIP STEM

K-Number: K121221 · 2012-08-09

ApplicantWrightmedicaltechnologyinc
Decision Date2012-08-09
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROFEMUR Z REVISION HIP STEM is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2012-08-09 under 510(k) number K121221. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFEMUR Z REVISION HIP STEM?

PROFEMUR Z REVISION HIP STEM is a medical device that received FDA 510(k) clearance on 2012-08-09. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K121221.

When did PROFEMUR Z REVISION HIP STEM receive FDA 510(k) clearance?

PROFEMUR Z REVISION HIP STEM received FDA 510(k) clearance on 2012-08-09, under 510(k) number K121221.

Who is the listed applicant for PROFEMUR Z REVISION HIP STEM?

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

What is the FDA product code for PROFEMUR Z REVISION HIP STEM?

The FDA product code for PROFEMUR Z REVISION HIP STEM is LZO.

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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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