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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 K111135
Device Name PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)
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 Number888.3060
Classification Product Code
KWQ  
Date Received04/22/2011
Decision Date 08/17/2011
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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