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FDA 510(k)

DEPUY SPA POROUS COATED PROXIMAL SLEEVE

K-Number: K071059 · 2007-11-09

ApplicantDePuy Orthopaedics, Inc.
Decision Date2007-11-09
Product CodeKWZ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY SPA POROUS COATED PROXIMAL SLEEVE 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 2007-11-09 under 510(k) number K071059. The device is classified under product code KWZ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY SPA POROUS COATED PROXIMAL SLEEVE?

DEPUY SPA POROUS COATED PROXIMAL SLEEVE is a medical device that received FDA 510(k) clearance on 2007-11-09. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K071059.

When did DEPUY SPA POROUS COATED PROXIMAL SLEEVE receive FDA 510(k) clearance?

DEPUY SPA POROUS COATED PROXIMAL SLEEVE received FDA 510(k) clearance on 2007-11-09, under 510(k) number K071059.

Who is the listed applicant for DEPUY SPA POROUS COATED PROXIMAL SLEEVE?

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 SPA POROUS COATED PROXIMAL SLEEVE?

The FDA product code for DEPUY SPA POROUS COATED PROXIMAL SLEEVE is KWZ.

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Other records listing DePuy Orthopaedics, Inc. as applicant

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Related Devices (Code: KWZ)

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.

K241461Mpact Constrained LinerMedacta International S.A.K240639PINNACLETM Constrained Acetabular LinersDepuy Ireland UCK162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture BoltEncore Medical L.P.K161610EXPRT Revision Hip SystemEncore Medical L.P.K122139SMITH & NEPHEW R3 CONSTRAINED LINERSSmith & Nephew, Inc.

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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