HIGH V+

Cement, Bone, Vertebroplasty

Teknimed, SAS

The following data is part of a premarket notification filed by Teknimed, Sas with the FDA for High V+.

Pre-market Notification Details

Device IDK161114
510k NumberK161114
Device Name:HIGH V+
ClassificationCement, Bone, Vertebroplasty
Applicant Teknimed, SAS 11, Rue D'Apollo L'union,  FR 31240
ContactJ.d. Webb
CorrespondentJ.d. Webb
The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock,  TX  78681
Product CodeNDN  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-20
Decision Date2017-04-12
Summary:summary

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