DYMAXEON SPINE SYSTEM

Thoracolumbosacral Pedicle Screw System

B2B SPINE PTY LTD

The following data is part of a premarket notification filed by B2b Spine Pty Ltd with the FDA for Dymaxeon Spine System.

Pre-market Notification Details

Device IDK121786
510k NumberK121786
Device Name:DYMAXEON SPINE SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant B2B SPINE PTY LTD 1331 H ST NW 12 FL Washington,  DC  20005
ContactJustin Eggleton
CorrespondentJustin Eggleton
B2B SPINE PTY LTD 1331 H ST NW 12 FL Washington,  DC  20005
Product CodeNKB  
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-18
Decision Date2012-11-05
Summary:summary

NIH GUDID Devices

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