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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 K103232
Device Name CASPIAN SPINAL SYSTEM
Applicant
K2M, INC.
751 MILLER DR.,SE
LEESBURG,  VA  20175
Applicant Contact NANCY GIEZEN
Correspondent
K2M, INC.
751 MILLER DR.,SE
LEESBURG,  VA  20175
Correspondent Contact NANCY GIEZEN
Regulation Number888.3050
Classification Product Code
KWP  
Date Received11/02/2010
Decision Date 01/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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