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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spinal vertebral body replacement device
510(K) Number K121889
Device Name STAXX XD SYSTEM
Applicant
SPINE WAVE, INC.
three enterprise dr.
suite 210
shelton,  CT  06484
Contact roaida rizkallah
Regulation Number888.3060
Classification Product Code
MQP  
Date Received06/28/2012
Decision Date 08/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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