CLAMPFIX

Thoracolumbosacral Pedicle Screw System

SYNTHES SPINE

The following data is part of a premarket notification filed by Synthes Spine with the FDA for Clampfix.

Pre-market Notification Details

Device IDK082914
510k NumberK082914
Device Name:CLAMPFIX
ClassificationThoracolumbosacral Pedicle Screw System
Applicant SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester,  PA  19380
ContactJason Lipman
CorrespondentJason Lipman
SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester,  PA  19380
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-30
Decision Date2008-12-11
Summary:summary

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