SYNTHES ZERO-P

Intervertebral Fusion Device With Integrated Fixation, Cervical

SYNTHES SPINE CO.LP

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

Pre-market Notification Details

Device IDK112459
510k NumberK112459
Device Name:SYNTHES ZERO-P
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester,  PA  19380
ContactStacey Bonnell
CorrespondentStacey Bonnell
SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester,  PA  19380
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-26
Decision Date2011-12-12
Summary:summary

NIH GUDID Devices

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