DEPUY VISION SOLUTION HIP PROSTHESIS

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

DEPUY, INC.

The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Vision Solution Hip Prosthesis.

Pre-market Notification Details

Device IDK953703
510k NumberK953703
Device Name:DEPUY VISION SOLUTION HIP PROSTHESIS
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
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 CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-08
Decision Date1996-02-01

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