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FDA 510(k)

PCA CONSTRAINED ACETABULAR LINERS

K-Number: K063445 · 2007-03-08

ApplicantHowmedica Osteonics Corp.
Decision Date2007-03-08
Product CodeKWZ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PCA CONSTRAINED ACETABULAR LINERS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2007-03-08 under 510(k) number K063445. 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 PCA CONSTRAINED ACETABULAR LINERS?

PCA CONSTRAINED ACETABULAR LINERS is a medical device that received FDA 510(k) clearance on 2007-03-08. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K063445.

When did PCA CONSTRAINED ACETABULAR LINERS receive FDA 510(k) clearance?

PCA CONSTRAINED ACETABULAR LINERS received FDA 510(k) clearance on 2007-03-08, under 510(k) number K063445.

Who is the listed applicant for PCA CONSTRAINED ACETABULAR LINERS?

The FDA 510(k) record lists Howmedica Osteonics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PCA CONSTRAINED ACETABULAR LINERS?

The FDA product code for PCA CONSTRAINED ACETABULAR LINERS is KWZ.

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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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