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FDA 510(k)

MICROPLASTY TIBIAL TRAYS

K-Number: K063732 · 2007-01-18

ApplicantBiomet Manufacturing Corp
Decision Date2007-01-18
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MICROPLASTY TIBIAL TRAYS 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 2007-01-18 under 510(k) number K063732. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROPLASTY TIBIAL TRAYS?

MICROPLASTY TIBIAL TRAYS is a medical device that received FDA 510(k) clearance on 2007-01-18. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K063732.

When did MICROPLASTY TIBIAL TRAYS receive FDA 510(k) clearance?

MICROPLASTY TIBIAL TRAYS received FDA 510(k) clearance on 2007-01-18, under 510(k) number K063732.

Who is the listed applicant for MICROPLASTY TIBIAL TRAYS?

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 MICROPLASTY TIBIAL TRAYS?

The FDA product code for MICROPLASTY TIBIAL TRAYS is JWH.

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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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