SYNTHES SCOUT VESSEL GUARD

Vessel Guard Or Cover

SYNTHES SPINE

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

Pre-market Notification Details

Device IDK103558
510k NumberK103558
Device Name:SYNTHES SCOUT VESSEL GUARD
ClassificationVessel Guard Or Cover
Applicant SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester,  PA  19380
ContactHeather Guerin
CorrespondentHeather Guerin
SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester,  PA  19380
Product CodeOMR  
CFR Regulation Number870.3470 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-02
Decision Date2011-02-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H98108650102S0 K103558 000
H98108650101S0 K103558 000

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