DEPUY MODULAR M HEADS

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Modular M Heads.

Pre-market Notification Details

Device IDK060031
510k NumberK060031
Device Name:DEPUY MODULAR M HEADS
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw,  IN  46580
ContactKeli K Hankee
CorrespondentKeli K Hankee
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw,  IN  46580
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-01-05
Decision Date2006-01-31
Summary:summary

NIH GUDID Devices

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