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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K052404
Device Name DENALI DEFORMITY SYSTEM
Applicant
K2m, LLC
751 Miller Dr., SE, Suite F1
Leesburg,  VA  20175
Applicant Contact RICHARD W WOODS
Correspondent
K2m, LLC
751 Miller Dr., SE, Suite F1
Leesburg,  VA  20175
Correspondent Contact RICHARD W WOODS
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received09/01/2005
Decision Date 05/23/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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