PATELLOFEMORAL JOINT PROSTHESIS

Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Patellofemoral Joint Prosthesis.

Pre-market Notification Details

Device IDK962190
510k NumberK962190
Device Name:PATELLOFEMORAL JOINT PROSTHESIS
ClassificationProsthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Applicant INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin,  TX  78717
ContactSam Mirza
CorrespondentSam Mirza
INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin,  TX  78717
Product CodeKRR  
CFR Regulation Number888.3540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-06
Decision Date1996-10-28
Summary:summary

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