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FDA 510(k)

ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT

K-Number: K936079 · 1994-09-07

ApplicantExactech, Inc.
Decision Date1994-09-07
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 1994-09-07 under 510(k) number K936079. 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 ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT?

ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT is a medical device that received FDA 510(k) clearance on 1994-09-07. The listed applicant is Exactech, Inc.. The 510(k) number is K936079.

When did ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT receive FDA 510(k) clearance?

ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT received FDA 510(k) clearance on 1994-09-07, under 510(k) number K936079.

Who is the listed applicant for ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT?

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

What is the FDA product code for ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT?

The FDA product code for ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT is JWH.

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Related Devices (Code: 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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