UHMWPE COMPONENTS-CHANGE IN PACKAGING

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Uhmwpe Components-change In Packaging.

Pre-market Notification Details

Device IDK940743
510k NumberK940743
Device Name:UHMWPE COMPONENTS-CHANGE IN PACKAGING
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Applicant DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw,  IN  46581 -0988
ContactDavid A Kotkovetz
CorrespondentDavid A Kotkovetz
DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw,  IN  46581 -0988
Product CodeKWY  
Subsequent Product CodeHRY
Subsequent Product CodeJDB
Subsequent Product CodeKWI
Subsequent Product CodeLZN
CFR Regulation Number888.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-16
Decision Date1995-09-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295318088 K940743 000
10603295318071 K940743 000
10603295318064 K940743 000

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