TRIFLANGE ACETABULAR CUP SYSTEM

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Triflange Acetabular Cup System.

Pre-market Notification Details

Device IDK001277
510k NumberK001277
Device Name:TRIFLANGE ACETABULAR CUP SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactMarcia J Arentz
CorrespondentMarcia J Arentz
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-04-21
Decision Date2000-06-23

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