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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K141873
Device Name RANGE/MESA/DENALI SPINAL SYSTEM
Applicant
K2M, INC.
751 miller dr se
leesburg,  VA  22066
Applicant Contact nancy glezen
Correspondent
K2M, INC.
751 miller dr se
leesburg,  VA  22066
Correspondent Contact nancy glezen
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI   OSH  
Date Received07/11/2014
Decision Date 09/08/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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