APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERT

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 Tibial Baseplate/knee Tibial Insert.

Pre-market Notification Details

Device IDK934381
510k NumberK934381
Device Name:APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERT
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
ContactJoann Ringer
CorrespondentJoann Ringer
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 Received1993-09-08
Decision Date1995-02-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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