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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K051454
Device Name ALEUTIAN SPACER SYSTEM
Applicant
K2M, LLC
751 MILLER DR.,S.E., SUITE F1
LEESBURG,  VA  20175
Applicant Contact RICH WOODS
Correspondent
K2M, LLC
751 MILLER DR.,S.E., SUITE F1
LEESBURG,  VA  20175
Correspondent Contact RICH WOODS
Regulation Number888.3060
Classification Product Code
MQP  
Date Received06/02/2005
Decision Date 07/27/2005
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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