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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K112037
Device Name RANGE SPINAL SYSTEM (MESA AND DENALI)
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 Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received07/18/2011
Decision Date 10/06/2011
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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