STAXX(R) XD 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 Staxx(r) Xd System.

Pre-market Notification Details

Device IDK102682
510k NumberK102682
Device Name:STAXX(R) XD SYSTEM
ClassificationSpinal Vertebral Body Replacement Device
Applicant SPINE WAVE, INC. 3 ENTERPRISE DR SUITE 210 Shelton,  CT  06484
ContactRoaiada Rizkallah
CorrespondentRoaiada Rizkallah
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 Received2010-09-17
Decision Date2010-11-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10840642100693 K102682 000
10840642100686 K102682 000

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