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FDA 510(k)

ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT

K-Number: K940235 · 1994-10-05

ApplicantWrightmedicaltechnologyinc
Decision Date1994-10-05
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ORTHOLOC ADVANTIM PS LSI 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 1994-10-05 under 510(k) number K940235. 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 ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT?

ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT is a medical device that received FDA 510(k) clearance on 1994-10-05. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K940235.

When did ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT receive FDA 510(k) clearance?

ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT received FDA 510(k) clearance on 1994-10-05, under 510(k) number K940235.

Who is the listed applicant for ORTHOLOC ADVANTIM PS LSI 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 ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT?

The FDA product code for ORTHOLOC ADVANTIM PS LSI 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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