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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 K220199
Device Name AFFINITY Proximal Tibia System
Applicant
Techfit Digital Surgery, Inc.
1511 Aviation Center Pkwy.
Suite 220h
Daytona Beach,  FL  32114
Applicant Contact Leidy Johanna Toro-Gonzalez
Correspondent
Techfit Digital Surgery, Inc.
1511 Aviation Center Pkwy.
Suite 220h
Daytona Beach,  FL  32114
Correspondent Contact Leidy Johanna Toro-Gonzalez
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/24/2022
Decision Date 03/21/2022
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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