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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, surgical, fiberoptic
510(k) Number K082992
Device Name AXXION LIGHT GUIDE
Applicant
SPINAL ELEMENTS, INC.
2744 LOKER AVE. W. SUITE 100
CARLSBAD,  CA  92010
Applicant Contact KERRI DIMARTINO
Correspondent
SPINAL ELEMENTS, INC.
2744 LOKER AVE. W. SUITE 100
CARLSBAD,  CA  92010
Correspondent Contact KERRI DIMARTINO
Regulation Number878.4580
Classification Product Code
FST  
Date Received10/07/2008
Decision Date 02/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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