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FDA 510(k)

REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT

K-Number: K053299 · 2006-01-05

ApplicantBiomet Manufacturing, Inc.
Decision Date2006-01-05
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing, Inc.. It received FDA 510(k) clearance on 2006-01-05 under 510(k) number K053299. The device is classified under product code HRY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT?

REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT is a medical device that received FDA 510(k) clearance on 2006-01-05. The listed applicant is Biomet Manufacturing, Inc.. The 510(k) number is K053299.

When did REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT receive FDA 510(k) clearance?

REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT received FDA 510(k) clearance on 2006-01-05, under 510(k) number K053299.

Who is the listed applicant for REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT?

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

What is the FDA product code for REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT?

The FDA product code for REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT is HRY.

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Other records listing Biomet Manufacturing, Inc. as applicant

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Related Devices (Code: HRY)

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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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