SYNTHES OC FUSION SYSTEM

Appliance, Fixation, Spinal Interlaminal

SYNTHES SPINE CO.LP

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

Pre-market Notification Details

Device IDK053418
510k NumberK053418
Device Name:SYNTHES OC FUSION SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
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 CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-08
Decision Date2006-09-06
Summary:summary

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