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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 K252661
Device Name SternaFuse Ti Fixation System
Applicant
Fusion Innovations, LLC
341 N. Maitland Ave.
#270
Maitland,  FL  32751
Applicant Contact Adam Cowick
Correspondent
Rook Quality Systems
1155 Mount Vernon Hwy
Suite 800
Dunwoody,  GA  30338
Correspondent Contact Sarah Robbins
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received08/22/2025
Decision Date 11/19/2025
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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