ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

ALPHATEC SPINE, INC.

The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Zodiac 4.0 Polyaxial Spinal Fixation System.

Pre-market Notification Details

Device IDK071890
510k NumberK071890
Device Name:ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad,  CA  92011
ContactMary Stanners
CorrespondentMary Stanners
ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad,  CA  92011
Product CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-09
Decision Date2007-11-09
Summary:summary

NIH GUDID Devices

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