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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
510(k) Number K123412
Device Name RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS
Applicant
K2M, INC.
751 MILLER DR., S.E., SUITE F1
Leesburg,  VA  20175
Applicant Contact NANCY GIEZEN
Correspondent
K2M, INC.
751 MILLER DR., S.E., SUITE F1
Leesburg,  VA  20175
Correspondent Contact NANCY GIEZEN
Regulation Number888.3070
Classification Product Code
OSH  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received11/06/2012
Decision Date 02/13/2013
Decision SE - With Limitations (SESU)
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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