MOST HEX INTRAMEDULLARY (I/M) STEM

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

SULZER ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Most Hex Intramedullary (i/m) Stem.

Pre-market Notification Details

Device IDK973087
510k NumberK973087
Device Name:MOST HEX INTRAMEDULLARY (I/M) STEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin,  TX  78717
ContactMitchell A Dhority
CorrespondentMitchell A Dhority
SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin,  TX  78717
Product CodeLZO  
Subsequent Product CodeJDI
Subsequent Product CodeKRO
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-18
Decision Date1997-11-14
Summary:summary

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