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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K121016
Device Name RANGE SPINAL SYSTEM (MESA AND DENALI)
Applicant
K2m, Inc.
751 Miller Dr., SE, Suite F1
Leesburg,  VA  20175
Applicant Contact NANCY GIEZEN
Correspondent
K2m, Inc.
751 Miller Dr., SE, Suite F1
Leesburg,  VA  20175
Correspondent Contact NANCY GIEZEN
Regulation Number888.3070
Classification Product Code
MNH  
Date Received04/04/2012
Decision Date 06/27/2012
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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