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FDA 510(k)

DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES

K-Number: K071417 · 2007-08-02

ApplicantDePuy Orthopaedics, Inc.
Decision Date2007-08-02
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY LPS DIAPHYSEAL AND 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 2007-08-02 under 510(k) number K071417. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES?

DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES is a medical device that received FDA 510(k) clearance on 2007-08-02. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K071417.

When did DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES receive FDA 510(k) clearance?

DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES received FDA 510(k) clearance on 2007-08-02, under 510(k) number K071417.

Who is the listed applicant for DEPUY LPS DIAPHYSEAL AND 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 LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES?

The FDA product code for DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES is MBH.

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Other records listing DePuy Orthopaedics, Inc. as applicant

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Related Devices (Code: MBH)

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.

K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.

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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