ANNEXTM ADJACENT LEVEL SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

SPINE WAVE, INC.

The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Annextm Adjacent Level System.

Pre-market Notification Details

Device IDK132403
510k NumberK132403
Device Name:ANNEXTM ADJACENT LEVEL SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant SPINE WAVE, INC. 3 ENTERPRISE DR. SUITE 210 Shelton,  CT  06484
ContactJoseph Mercado
CorrespondentJoseph Mercado
SPINE WAVE, INC. 3 ENTERPRISE DR. SUITE 210 Shelton,  CT  06484
Product CodeMNH  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-01
Decision Date2014-01-10
Summary:summary

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