FREEMAN-SAMUELSON MODULAR TOTAL KNEE REPLACEMENT

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

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Freeman-samuelson Modular Total Knee Replacement.

Pre-market Notification Details

Device IDK911972
510k NumberK911972
Device Name:FREEMAN-SAMUELSON MODULAR TOTAL KNEE REPLACEMENT
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
ContactWebb
CorrespondentWebb
INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-03
Decision Date1991-10-25

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