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FDA 510(k)

PROFIX POSTERIOR-STABILIZED KNEE SYSTEM

K-Number: K954909 · 1996-01-31

ApplicantSmith & Nephew Richards, Inc.
Decision Date1996-01-31
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

PROFIX POSTERIOR-STABILIZED KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Richards, Inc.. It received FDA 510(k) clearance on 1996-01-31 under 510(k) number K954909. 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 PROFIX POSTERIOR-STABILIZED KNEE SYSTEM?

PROFIX POSTERIOR-STABILIZED KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1996-01-31. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K954909.

When did PROFIX POSTERIOR-STABILIZED KNEE SYSTEM receive FDA 510(k) clearance?

PROFIX POSTERIOR-STABILIZED KNEE SYSTEM received FDA 510(k) clearance on 1996-01-31, under 510(k) number K954909.

Who is the listed applicant for PROFIX POSTERIOR-STABILIZED KNEE SYSTEM?

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

What is the FDA product code for PROFIX POSTERIOR-STABILIZED KNEE SYSTEM?

The FDA product code for PROFIX POSTERIOR-STABILIZED KNEE SYSTEM is JWH.

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Other records listing Smith & Nephew Richards, Inc. as applicant

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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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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