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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 K071151
Device Name TENSION BAND ANTERIOR SPINAL SYSTEM
Applicant
Spinal Instrumentation Simplification Systems, LLC
8202 Sherman Rd.
Chseterland,  OH  44026
Applicant Contact KAREN E WARDEN
Correspondent
Spinal Instrumentation Simplification Systems, LLC
8202 Sherman Rd.
Chseterland,  OH  44026
Correspondent Contact KAREN E WARDEN
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received04/25/2007
Decision Date 11/07/2007
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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