TITAN POROCOAT HIP PROSTHESIS

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 Titan Porocoat Hip Prosthesis.

Pre-market Notification Details

Device IDK001991
510k NumberK001991
Device Name:TITAN POROCOAT HIP PROSTHESIS
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 Received2000-06-29
Decision Date2000-08-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.