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FDA 510(k)

REGENEREX PATELLA COMPONENTS

K-Number: K083782 · 2009-04-03

ApplicantBiomet Manufacturing Corp
Decision Date2009-04-03
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REGENEREX PATELLA COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2009-04-03 under 510(k) number K083782. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REGENEREX PATELLA COMPONENTS?

REGENEREX PATELLA COMPONENTS is a medical device that received FDA 510(k) clearance on 2009-04-03. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K083782.

When did REGENEREX PATELLA COMPONENTS receive FDA 510(k) clearance?

REGENEREX PATELLA COMPONENTS received FDA 510(k) clearance on 2009-04-03, under 510(k) number K083782.

Who is the listed applicant for REGENEREX PATELLA COMPONENTS?

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

What is the FDA product code for REGENEREX PATELLA COMPONENTS?

The FDA product code for REGENEREX PATELLA COMPONENTS is MBH.

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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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