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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K140283
Device Name OSTEOMED EXTREMIFUSE SYSTEM
Applicant
Osteomed
3885 Arapaho Rd.
Addison,  TX  75001
Applicant Contact BLESSON ABRAHAM
Correspondent
Osteomed
3885 Arapaho Rd.
Addison,  TX  75001
Correspondent Contact BLESSON ABRAHAM
Regulation Number888.3040
Classification Product Code
HWC  
Date Received02/04/2014
Decision Date 02/28/2014
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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