INSALL-BURSTEIN II

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

HOSPITAL FOR SPECIAL SURGERY

The following data is part of a premarket notification filed by Hospital For Special Surgery with the FDA for Insall-burstein Ii.

Pre-market Notification Details

Device IDK935080
510k NumberK935080
Device Name:INSALL-BURSTEIN II
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant HOSPITAL FOR SPECIAL SURGERY 535 EAST 70 ST. New York,  NY  10021
ContactBruce H Robie
CorrespondentBruce H Robie
HOSPITAL FOR SPECIAL SURGERY 535 EAST 70 ST. New York,  NY  10021
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-25
Decision Date1995-05-22

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