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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 K121630
Device Name RANGE SPINAL SYSTEM
Original Applicant
K2M, INC.
751 miller dr., s.e., suite f1
leesburg,  VA  20175
Original Contact nancy giezen
Regulation Number888.3070
Classification Product Code
OSH  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received06/04/2012
Decision Date 09/11/2012
Decision substantially equivalent - with limitations (SU)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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