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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 K202680
Device Name OsteoMed ExtremiFix Mini & Small Cannulated Screw System
Applicant
Osteomed, LLC
3885 Arapaho Rd.
Addison,  TX  75001
Applicant Contact Andrew "Drew" Johnson
Correspondent
Osteomed, LLC
3885 Arapaho Rd.
Addison,  TX  75001
Correspondent Contact Andrew "Drew" Johnson
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received09/15/2020
Decision Date 10/15/2020
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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