SYNAPSE SYSTEM

Orthosis, Spinal Pedicle Fixation

SYNTHES SPINE CO.LP

The following data is part of a premarket notification filed by Synthes Spine Co.lp with the FDA for Synapse System.

Pre-market Notification Details

Device IDK070573
510k NumberK070573
Device Name:SYNAPSE SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester,  PA  19380
ContactSusan Lewandowski
CorrespondentSusan Lewandowski
SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester,  PA  19380
Product CodeMNI  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-02-28
Decision Date2007-06-08
Summary:summary

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