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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K020562
Device Name APEX INTRAMEDULLARY NAIL SYSTEM
Applicant
Magly Orthopedics, LLC
15009 NE 195th St.
Woodinville,  WA  98072
Applicant Contact DAVE STINSON
Correspondent
Magly Orthopedics, LLC
15009 NE 195th St.
Woodinville,  WA  98072
Correspondent Contact DAVE STINSON
Regulation Number888.3020
Classification Product Code
HSB  
Date Received02/20/2002
Decision Date 05/16/2002
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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