PROFILE FEMORAL HIP PROSTHESIS W/POROCOAT

Prosthesis, Hip, Hemi-, Femoral, Metal

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Profile Femoral Hip Prosthesis W/porocoat.

Pre-market Notification Details

Device IDK872776
510k NumberK872776
Device Name:PROFILE FEMORAL HIP PROSTHESIS W/POROCOAT
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal
Applicant DEPUY, INC. P.O. BOX 988 Warsaw,  IN  46581 -0988
ContactBarry R Sisson
CorrespondentBarry R Sisson
DEPUY, INC. P.O. BOX 988 Warsaw,  IN  46581 -0988
Product CodeKWL  
CFR Regulation Number888.3360 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-14
Decision Date1987-08-24

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