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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 K142558
Device Name Caspian OCT/MESA Mini/DENALI Mini Spinal System
Applicant
K2m
751 Miller Dr. SE
Leesburg,  VA  20175
Applicant Contact Nancy Giezen
Correspondent
K2m
751 Miller Dr. SE
Leesburg,  VA  20175
Correspondent Contact Nancy Giezen
Regulation Number888.3050
Classification Product Code
KWP  
Date Received09/11/2014
Decision Date 12/22/2014
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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