MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

SULZER MEDICA

The following data is part of a premarket notification filed by Sulzer Medica with the FDA for Modified To Modular Fr Severe Bone Loss Trauma.

Pre-market Notification Details

Device IDK002324
510k NumberK002324
Device Name:MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant SULZER MEDICA 9900 SPECTRUM DR. Austin,  TX  78717
ContactFrances E Harrison
CorrespondentFrances E Harrison
SULZER MEDICA 9900 SPECTRUM DR. Austin,  TX  78717
Product CodeJDI  
Subsequent Product CodeKRO
Subsequent Product CodeLZO
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-31
Decision Date2000-08-24

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