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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Equipment, Traction, Powered
510(k) Number K103248
Device Name INTEGRITY SPINAL CARE SYSTEM
Applicant
Integra Life Sciences
5795 S. Sandhill Rd.
Suite F,
Las Vegas,  NV  89120
Applicant Contact JAMES J GIBSON
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Regulation Number890.5900
Classification Product Code
ITH  
Date Received11/03/2010
Decision Date 04/05/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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