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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K082821
Device Name SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE 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
KWQ  
Date Received09/25/2008
Decision Date 10/31/2008
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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