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FDA 510(k)

METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY

K-Number: K120362 · 2012-05-04

ApplicantCorin USA
Decision Date2012-05-04
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 2012-05-04 under 510(k) number K120362. 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 METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY?

METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY is a medical device that received FDA 510(k) clearance on 2012-05-04. The listed applicant is Corin USA. The 510(k) number is K120362.

When did METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY receive FDA 510(k) clearance?

METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY received FDA 510(k) clearance on 2012-05-04, under 510(k) number K120362.

Who is the listed applicant for METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY?

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

What is the FDA product code for METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY?

The FDA product code for METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY 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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