NATURAL-KNEE SYSTEM SYSTEM W/COCR/CSTI(TM)

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 Natural-knee System System W/cocr/csti(tm).

Pre-market Notification Details

Device IDK902335
510k NumberK902335
Device Name:NATURAL-KNEE SYSTEM SYSTEM W/COCR/CSTI(TM)
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
ContactThomas L Craig
CorrespondentThomas L Craig
INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-05-24
Decision Date1990-08-22

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