CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G

Cement, Bone, Vertebroplasty

MEDOS INTERNATIONAL SARL

The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Confidence High Viscosity Spinal Cement, 16g / 20g.

Pre-market Notification Details

Device IDK112907
510k NumberK112907
Device Name:CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G
ClassificationCement, Bone, Vertebroplasty
Applicant MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham,  MA  02767
ContactRobin Dinardo
CorrespondentRobin Dinardo
MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham,  MA  02767
Product CodeNDN  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-03
Decision Date2011-12-22
Summary:summary

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