P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)

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

JOHNSON & JOHNSON PROFESSIONALS, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for P.f.c. Sigma Knee System (size 1.5).

Pre-market Notification Details

Device IDK971189
510k NumberK971189
Device Name:P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
ContactJohn Ferros
CorrespondentJohn Ferros
JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-01
Decision Date1997-07-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10603295232520 K971189 000
10603295234036 K971189 000
10603295234012 K971189 000
10603295233992 K971189 000
10603295233985 K971189 000
10603295233978 K971189 000
10603295233961 K971189 000
10603295233954 K971189 000

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