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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 K203479
Device Name ExtremiLOCK Lateral Ankle Fusion Plates
Applicant
Osteomed
3885 Arapaho Rd.
Addison,  TX  75001
Applicant Contact Andrew Johnson
Correspondent
Osteomed
3885 Arapaho Rd.
Addison,  TX  75001
Correspondent Contact Andrew Johnson
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC  
Date Received11/27/2020
Decision Date 02/24/2021
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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