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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 K202914
Device Name SternaFuse Fixation System
Applicant
Fusion Innovations, LLC
116 E Main St. Suite 201
Rock Hill,  SC  29732
Applicant Contact Mark Schumacher
Correspondent
Kapstone Medical, LLC
520 Elliot St.
Charlotte,  NC  28202
Correspondent Contact Katelyn Jessup
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received09/29/2020
Decision Date 01/26/2022
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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