SYNTHES ZERO-P

Intervertebral Fusion Device With Integrated Fixation, Cervical

SYNTHES SPINE

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

Pre-market Notification Details

Device IDK093762
510k NumberK093762
Device Name:SYNTHES ZERO-P
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester,  PA  19380
ContactAmnon Talmor
CorrespondentAmnon Talmor
SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester,  PA  19380
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-07
Decision Date2010-12-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H981SD036179620 K093762 000

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