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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 K161369
Device Name EVEREST Spinal System
Applicant
K2m, Incorporated
600 Hope Pkwy. SE
Leesburg,  VA  20175
Applicant Contact NANCY GIEZEN
Correspondent
K2m
600 Hope Pkwy. Southeast
Leesburg,  VA  20175
Correspondent Contact NANCY GIEZEN
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI   OSH  
Date Received05/17/2016
Decision Date 07/21/2016
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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