TITANIUM HIP 1019

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 Titanium Hip 1019.

Pre-market Notification Details

Device IDK843909
510k NumberK843909
Device Name:TITANIUM HIP 1019
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant DEPUY, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
ContactStephen M Doyle
CorrespondentStephen M Doyle
DEPUY, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-10-03
Decision Date1984-11-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295033196 K843909 000
10603295033189 K843909 000
10603295033172 K843909 000
10603295033110 K843909 000
10603295033103 K843909 000
10603295033097 K843909 000
10603295033080 K843909 000
10603295033073 K843909 000
10603295033066 K843909 000

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