NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

ALPHATEC SPINE, INC.

The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Next Generation Anterior Cervical Plating System.

Pre-market Notification Details

Device IDK070681
510k NumberK070681
Device Name:NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad,  CA  92011
ContactPaula Morgan
CorrespondentPaula Morgan
ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad,  CA  92011
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-12
Decision Date2007-05-04
Summary:summary

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