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FDA 510(k)

ADVANCE MODULAR TIBIAL COMPONENT

K-Number: K973524 · 1997-12-12

ApplicantWrightmedicaltechnologyinc
Decision Date1997-12-12
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ADVANCE MODULAR TIBIAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 1997-12-12 under 510(k) number K973524. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ADVANCE MODULAR TIBIAL COMPONENT?

ADVANCE MODULAR TIBIAL COMPONENT is a medical device that received FDA 510(k) clearance on 1997-12-12. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K973524.

When did ADVANCE MODULAR TIBIAL COMPONENT receive FDA 510(k) clearance?

ADVANCE MODULAR TIBIAL COMPONENT received FDA 510(k) clearance on 1997-12-12, under 510(k) number K973524.

Who is the listed applicant for ADVANCE MODULAR TIBIAL COMPONENT?

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 MODULAR TIBIAL COMPONENT?

The FDA product code for ADVANCE MODULAR TIBIAL COMPONENT 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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