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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 K120899
Device Name RANGE SPINAL SYSTEM, UNIT ROD
Original Applicant
K2M, INC.
751 miller dr., s.e., suite f1
leesburg,  VA  20175
Original Contact nancy giezen
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received03/26/2012
Decision Date 05/25/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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