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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K123461
Device Name STAXX(R) IB 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 Number888.3080
Classification Product Code
MAX  
Date Received11/09/2012
Decision Date 04/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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