ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX

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 Adjustable Bridges, Models 11-20xx,11-25xx,11-30xx,11-35xx.

Pre-market Notification Details

Device IDK061321
510k NumberK061321
Device Name:ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
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 CodeMNH  
Subsequent Product CodeKWP
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-05-11
Decision Date2006-07-07
Summary:summary

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