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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 Intervertebral Body
510(k) Number K172104
Device Name Ozark(tm) Cervical Plate System
Applicant
K2m,Inc.
600 Hope Pkwy. SE
Leesburg,  VA  20175
Applicant Contact Nancy Giezen
Correspondent
Backroads Consulting, Inc.
P.O. Box 566
Chesterland,  OH  44026
Correspondent Contact Karen E. Warden
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received07/12/2017
Decision Date 08/23/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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