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FDA 510(k)

ADVANCE A-CLASS TIBIAL INSERT

K-Number: K081479 · 2009-02-20

ApplicantWrightmedicaltechnologyinc
Decision Date2009-02-20
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ADVANCE A-CLASS TIBIAL INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2009-02-20 under 510(k) number K081479. 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 ADVANCE A-CLASS TIBIAL INSERT?

ADVANCE A-CLASS TIBIAL INSERT is a medical device that received FDA 510(k) clearance on 2009-02-20. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K081479.

When did ADVANCE A-CLASS TIBIAL INSERT receive FDA 510(k) clearance?

ADVANCE A-CLASS TIBIAL INSERT received FDA 510(k) clearance on 2009-02-20, under 510(k) number K081479.

Who is the listed applicant for ADVANCE A-CLASS TIBIAL INSERT?

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

What is the FDA product code for ADVANCE A-CLASS TIBIAL INSERT?

The FDA product code for ADVANCE A-CLASS TIBIAL INSERT 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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