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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 K182473
Device Name PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems
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, Ph.D.
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received09/10/2018
Decision Date 12/12/2018
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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