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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 Interlaminal
510(k) Number K013196
Device Name ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM
Applicant
Spinal Innovations, LLC
7850 Stage Hills Blvd.
Suite 105
Bartlett,  TN  38133
Applicant Contact KENNETH RUSSELL
Correspondent
Spinal Innovations, LLC
7850 Stage Hills Blvd.
Suite 105
Bartlett,  TN  38133
Correspondent Contact KENNETH RUSSELL
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNH  
Date Received09/25/2001
Decision Date 01/30/2002
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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