FDA 510(k)

DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER

K-Number: K010171 · 2001-04-06

Decision Date2001-04-06

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER 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 2001-04-06 under 510(k) number K010171. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER?

DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER is a medical device that received FDA 510(k) clearance on 2001-04-06. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K010171.

When did DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER receive FDA 510(k) clearance?

DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER received FDA 510(k) clearance on 2001-04-06, under 510(k) number K010171.

Who is the listed applicant for DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER?

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 DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER?

The FDA product code for DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER is LPH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.