SEC VBR

Spinal Vertebral Body Replacement Device

INNVOTEC SURGICAL, INC.

The following data is part of a premarket notification filed by Innvotec Surgical, Inc. with the FDA for Sec Vbr.

Pre-market Notification Details

Device IDK091743
510k NumberK091743
Device Name:SEC VBR
ClassificationSpinal Vertebral Body Replacement Device
Applicant INNVOTEC SURGICAL, INC. 1331 H STREET NW 12TH FLOOR Washington,  DC  20005
ContactJustin Eggleton
CorrespondentJustin Eggleton
INNVOTEC SURGICAL, INC. 1331 H STREET NW 12TH FLOOR Washington,  DC  20005
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-16
Decision Date2009-11-02
Summary:summary

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