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FDA 510(k)

DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES

K-Number: K063633 · 2007-03-02

ApplicantDePuy Orthopaedics, Inc.
Decision Date2007-03-02
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2007-03-02 under 510(k) number K063633. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES?

DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES is a medical device that received FDA 510(k) clearance on 2007-03-02. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K063633.

When did DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES receive FDA 510(k) clearance?

DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES received FDA 510(k) clearance on 2007-03-02, under 510(k) number K063633.

Who is the listed applicant for DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES?

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

What is the FDA product code for DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES?

The FDA product code for DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES is JWH.

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Other records listing DePuy Orthopaedics, 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.

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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