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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K161041
Device Name OsteoMed ExtremiLOCK Wrist Plating System
Applicant
Osteomed
3885 Arapaho Rd.
Addison,  TX  75001
Applicant Contact KATHRYN JAYNE
Correspondent
Osteomed
3885 Arapaho Rd.
Addison,  TX  75001
Correspondent Contact KATHRYN JAYNE
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received04/13/2016
Decision Date 05/19/2016
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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