APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA

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 Apollo Total Knee System Single Lug Patella.

Pre-market Notification Details

Device IDK960535
510k NumberK960535
Device Name:APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin,  TX  78717
ContactMitchell A Dhority
CorrespondentMitchell A Dhority
INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin,  TX  78717
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-02-07
Decision Date1996-04-23
Summary:summary

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