P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT

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. 2 Total Hip System Porous Coated Modular Femoral Component.

Pre-market Notification Details

Device IDK935452
510k NumberK935452
Device Name:P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant JOHNSON & JOHNSON ORTHOPAEDICS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
ContactMarsha J Stone
CorrespondentMarsha J Stone
JOHNSON & JOHNSON ORTHOPAEDICS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-11-12
Decision Date1994-10-06

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