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FDA 510(k)

EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT

K-Number: K935773 · 1994-12-09

ApplicantExactech, Inc.
Decision Date1994-12-09
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 1994-12-09 under 510(k) number K935773. 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 EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT?

EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1994-12-09. The listed applicant is Exactech, Inc.. The 510(k) number is K935773.

When did EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT receive FDA 510(k) clearance?

EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT received FDA 510(k) clearance on 1994-12-09, under 510(k) number K935773.

Who is the listed applicant for EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT?

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 EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT?

The FDA product code for EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT is JWH.

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Other records listing Exactech, Inc. as applicant

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Related Devices (Code: JWH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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