SPINE-FIX BIOMIMETIC BONE CEMENT

Cement, Bone, Vertebroplasty

TEKNIMED SA

The following data is part of a premarket notification filed by Teknimed Sa with the FDA for Spine-fix Biomimetic Bone Cement.

Pre-market Notification Details

Device IDK043593
510k NumberK043593
Device Name:SPINE-FIX BIOMIMETIC BONE CEMENT
ClassificationCement, Bone, Vertebroplasty
Applicant TEKNIMED SA 1001 OAKWOOD BLVD Round Rock,  TX  78681
ContactJ. D. Webb
CorrespondentJ. D. Webb
TEKNIMED SA 1001 OAKWOOD BLVD Round Rock,  TX  78681
Product CodeNDN  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-29
Decision Date2006-03-17
Summary:summary

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