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FDA 510(k)

ADVANCE ULTRA-CONGRUENT TIBIAL INSERT

K-Number: K972770 · 1997-10-21

ApplicantWrightmedicaltechnologyinc
Decision Date1997-10-21
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ADVANCE ULTRA-CONGRUENT 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 1997-10-21 under 510(k) number K972770. 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 ADVANCE ULTRA-CONGRUENT TIBIAL INSERT?

ADVANCE ULTRA-CONGRUENT TIBIAL INSERT is a medical device that received FDA 510(k) clearance on 1997-10-21. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K972770.

When did ADVANCE ULTRA-CONGRUENT TIBIAL INSERT receive FDA 510(k) clearance?

ADVANCE ULTRA-CONGRUENT TIBIAL INSERT received FDA 510(k) clearance on 1997-10-21, under 510(k) number K972770.

Who is the listed applicant for ADVANCE ULTRA-CONGRUENT 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 ULTRA-CONGRUENT TIBIAL INSERT?

The FDA product code for ADVANCE ULTRA-CONGRUENT TIBIAL INSERT 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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