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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K132126
Device Name SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM
Applicant
Spectrum Spine, LLC
100 E. S. Main St., P.O. Box 1458
Waxhaw,  NC  28173
Applicant Contact OTTIE PENDLETON
Correspondent
Spectrum Spine, LLC
100 E. S. Main St., P.O. Box 1458
Waxhaw,  NC  28173
Correspondent Contact OTTIE PENDLETON
Classification Product Code
MRW  
Date Received07/10/2013
Decision Date 10/28/2013
Decision Substantially Equivalent (SESE)
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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