ALL POLYETHYLENE CEMENTED ACETABULAR CUP

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 All Polyethylene Cemented Acetabular Cup.

Pre-market Notification Details

Device IDK943696
510k NumberK943696
Device Name:ALL POLYETHYLENE CEMENTED ACETABULAR CUP
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactCheryl Hastings
CorrespondentCheryl Hastings
DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-29
Decision Date1995-05-17

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