ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM

Orthosis, Spinal Pedicle Fixation

ALPHATEC SPINE, INC.

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

Pre-market Notification Details

Device IDK093077
510k NumberK093077
Device Name:ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad,  CA  92008
ContactCheryl Allen
CorrespondentCheryl Allen
ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad,  CA  92008
Product CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-30
Decision Date2009-12-23
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.