P.F.C. CERAMIC HIP HEAD

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

JOHNSON & JOHNSON ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Orthopaedics, Inc. with the FDA for P.f.c. Ceramic Hip Head.

Pre-market Notification Details

Device IDK933275
510k NumberK933275
Device Name:P.F.C. CERAMIC HIP HEAD
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham,  MA  02767
ContactCaroline F Lee
CorrespondentCaroline F Lee
JOHNSON & JOHNSON ORTHOPAEDICS, INC. Raynham,  MA  02767
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-06
Decision Date1994-09-28

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