FDA 510(k)

MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS

K-Number: K994415 · 2000-02-03

Decision Date2000-02-03

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS 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 2000-02-03 under 510(k) number K994415. 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 MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS?

MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS is a medical device that received FDA 510(k) clearance on 2000-02-03. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K994415.

When did MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS receive FDA 510(k) clearance?

MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS received FDA 510(k) clearance on 2000-02-03, under 510(k) number K994415.

Who is the listed applicant for MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS?

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 MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS?

The FDA product code for MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS 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.