P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

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. Total Knee System Oval Patella.

Pre-market Notification Details

Device IDK935262
510k NumberK935262
Device Name:P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
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 CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-11-03
Decision Date1994-06-03

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