APOLLO KNEE FEMORAL SPACERS

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

SULZER ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Apollo Knee Femoral Spacers.

Pre-market Notification Details

Device IDK971770
510k NumberK971770
Device Name:APOLLO KNEE FEMORAL SPACERS
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin,  TX  78717
ContactJacquelyn Hughes
CorrespondentJacquelyn Hughes
SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin,  TX  78717
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-13
Decision Date1997-07-31

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