APOLLO KNEE FEMORAL COMPONENT

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 Knee Femoral Component.

Pre-market Notification Details

Device IDK933229
510k NumberK933229
Device Name:APOLLO KNEE FEMORAL COMPONENT
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant INTERMEDICS ORTHOPEDICS 1300-C EAST ANDERSON LN. Austin,  TX  78752
ContactJoann Ringer
CorrespondentJoann Ringer
INTERMEDICS ORTHOPEDICS 1300-C EAST ANDERSON LN. Austin,  TX  78752
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-02
Decision Date1995-01-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024262331 K933229 000

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