STAXXSD SYSTEM

Spinal Vertebral Body Replacement Device

SPINE WAVE, INC.

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

Pre-market Notification Details

Device IDK111469
510k NumberK111469
Device Name:STAXXSD SYSTEM
ClassificationSpinal Vertebral Body Replacement Device
Applicant SPINE WAVE, INC. 3 ENTERPRISE DR SUITE 210 Shelton,  CT  06484
ContactDenise Duchene
CorrespondentDenise Duchene
SPINE WAVE, INC. 3 ENTERPRISE DR SUITE 210 Shelton,  CT  06484
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-27
Decision Date2011-07-19
Summary:summary

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