MOST OPTIONS SYSTEM

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

SULZER ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Most Options System.

Pre-market Notification Details

Device IDK013031
510k NumberK013031
Device Name:MOST OPTIONS SYSTEM
ClassificationProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Applicant SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin,  TX  78717
ContactFrances E Harrison
CorrespondentFrances E Harrison
SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin,  TX  78717
Product CodeKRO  
CFR Regulation Number888.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-09-10
Decision Date2001-12-07
Summary:summary

NIH GUDID Devices

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