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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 K080971
Device Name SPINESMITH CIMPLICITY SPINAL SYSTEM
Applicant
Spine Smith Partners L.P.
8140 N. Mopac
Bldg. Ii, Suite 120
Austin,  TX  78759
Applicant Contact ROBERT JONES
Correspondent
Spine Smith Partners L.P.
8140 N. Mopac
Bldg. Ii, Suite 120
Austin,  TX  78759
Correspondent Contact ROBERT JONES
Regulation Number888.3060
Classification Product Code
MQP  
Subsequent Product Code
ODP  
Date Received04/04/2008
Decision Date 07/02/2008
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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