F20

Cement, Bone, Vertebroplasty

TEKNIMED SA

The following data is part of a premarket notification filed by Teknimed Sa with the FDA for F20.

Pre-market Notification Details

Device IDK103433
510k NumberK103433
Device Name:F20
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-24
Decision Date2011-01-03

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