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FDA 510(k)

OFFSET TIBIAL TRAY

K-Number: K010212 · 2001-02-14

ApplicantBiomet, Inc.
Decision Date2001-02-14
Product CodeMBV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OFFSET TIBIAL TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2001-02-14 under 510(k) number K010212. The device is classified under product code MBV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OFFSET TIBIAL TRAY?

OFFSET TIBIAL TRAY is a medical device that received FDA 510(k) clearance on 2001-02-14. The listed applicant is Biomet, Inc.. The 510(k) number is K010212.

When did OFFSET TIBIAL TRAY receive FDA 510(k) clearance?

OFFSET TIBIAL TRAY received FDA 510(k) clearance on 2001-02-14, under 510(k) number K010212.

Who is the listed applicant for OFFSET TIBIAL TRAY?

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

What is the FDA product code for OFFSET TIBIAL TRAY?

The FDA product code for OFFSET TIBIAL TRAY is MBV.

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Related Devices (Code: MBV)

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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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