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FDA 510(k)

PROFEMUR RENAISSANCE CLASSIC HIP STEM

K-Number: K130984 · 2013-05-24

ApplicantWrightmedicaltechnologyinc
Decision Date2013-05-24
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROFEMUR RENAISSANCE CLASSIC 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 2013-05-24 under 510(k) number K130984. 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 RENAISSANCE CLASSIC HIP STEM?

PROFEMUR RENAISSANCE CLASSIC HIP STEM is a medical device that received FDA 510(k) clearance on 2013-05-24. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K130984.

When did PROFEMUR RENAISSANCE CLASSIC HIP STEM receive FDA 510(k) clearance?

PROFEMUR RENAISSANCE CLASSIC HIP STEM received FDA 510(k) clearance on 2013-05-24, under 510(k) number K130984.

Who is the listed applicant for PROFEMUR RENAISSANCE CLASSIC 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 RENAISSANCE CLASSIC HIP STEM?

The FDA product code for PROFEMUR RENAISSANCE CLASSIC HIP STEM is LZO.

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Related Devices (Code: 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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