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FDA 510(k)

EPSILON DURASUL CONSTRAINED ACETABULAR LINER

K-Number: K030923 · 2003-10-03

ApplicantCenterpulse Orthopedics, Inc.
Decision Date2003-10-03
Product CodeKWZ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EPSILON DURASUL CONSTRAINED ACETABULAR LINER is the device name listed in this FDA 510(k) record. The listed applicant is Centerpulse Orthopedics, Inc.. It received FDA 510(k) clearance on 2003-10-03 under 510(k) number K030923. 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 EPSILON DURASUL CONSTRAINED ACETABULAR LINER?

EPSILON DURASUL CONSTRAINED ACETABULAR LINER is a medical device that received FDA 510(k) clearance on 2003-10-03. The listed applicant is Centerpulse Orthopedics, Inc.. The 510(k) number is K030923.

When did EPSILON DURASUL CONSTRAINED ACETABULAR LINER receive FDA 510(k) clearance?

EPSILON DURASUL CONSTRAINED ACETABULAR LINER received FDA 510(k) clearance on 2003-10-03, under 510(k) number K030923.

Who is the listed applicant for EPSILON DURASUL CONSTRAINED ACETABULAR LINER?

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

What is the FDA product code for EPSILON DURASUL CONSTRAINED ACETABULAR LINER?

The FDA product code for EPSILON DURASUL CONSTRAINED ACETABULAR LINER is KWZ.

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Other records listing Centerpulse Orthopedics, Inc. as applicant

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.

K033943ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODEDK033634EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODEDK040947DURASUL BIPOLARK033810NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEMK033664MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEMK032348CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP

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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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