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FDA 510(k)

LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS

K-Number: K101730 · 2010-12-03

ApplicantZimmer, Inc.
Decision Date2010-12-03
Product CodeKWZ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2010-12-03 under 510(k) number K101730. 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 LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS?

LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS is a medical device that received FDA 510(k) clearance on 2010-12-03. The listed applicant is Zimmer, Inc.. The 510(k) number is K101730.

When did LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS receive FDA 510(k) clearance?

LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS received FDA 510(k) clearance on 2010-12-03, under 510(k) number K101730.

Who is the listed applicant for LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS?

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

What is the FDA product code for LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS?

The FDA product code for LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED 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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