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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 K182684
Device Name HammerTechTM Fixation System
Applicant
Fusion Orthopedics, LLC
4135 S. Power Rd., Suite 110
Mesa,  AZ  85212
Applicant Contact Eli Jacobson
Correspondent
Fusion Orthopedics, LLC
4135 S. Power Rd., Suite 110
Mesa,  AZ  85212
Correspondent Contact Eli Jacobson
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTY  
Date Received09/26/2018
Decision Date 11/23/2018
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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