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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
Applicant Contact ROAIDA RIZKALLAH
Correspondent
Spine Wave, Inc.
Three Enterprise Dr.
Suite 210
Shelton,  CT  06484
Correspondent Contact ROAIDA RIZKALLAH
Regulation Number888.3060
Classification Product Code
MQP  
Date Received06/28/2012
Decision Date 08/29/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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