STANDARD POROCOAT MODIFIED MEDIAL ASPECT AML HIP

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Standard Porocoat Modified Medial Aspect Aml Hip.

Pre-market Notification Details

Device IDK870699
510k NumberK870699
Device Name:STANDARD POROCOAT MODIFIED MEDIAL ASPECT AML HIP
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant DEPUY, INC. P.O. BOX 988 Warsaw,  IN  46581 -0988
ContactSteven J Wentworth
CorrespondentSteven J Wentworth
DEPUY, INC. P.O. BOX 988 Warsaw,  IN  46581 -0988
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-02-19
Decision Date1987-05-01

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