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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 Integrated Fixation, Lumbar
510(k) Number K082926
Device Name ZUMA, MODEL 55-XXXX/56-XXXX
Applicant
Seaspine, Inc.
2302 La Mirada Dr.
Vista,  CA  92081
Applicant Contact JEFF BRITTAN
Correspondent
Seaspine, Inc.
2302 La Mirada Dr.
Vista,  CA  92081
Correspondent Contact JEFF BRITTAN
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Code
MQP  
Date Received10/01/2008
Decision Date 12/22/2008
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
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