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FDA 510(k)

EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM

K-Number: K933494 · 1995-03-10

ApplicantExactech, Inc.
Decision Date1995-03-10
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 1995-03-10 under 510(k) number K933494. 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 POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM?

EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1995-03-10. The listed applicant is Exactech, Inc.. The 510(k) number is K933494.

When did EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM receive FDA 510(k) clearance?

EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM received FDA 510(k) clearance on 1995-03-10, under 510(k) number K933494.

Who is the listed applicant for EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM?

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 POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM?

The FDA product code for EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM is JWH.

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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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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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