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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 K241995
Device Name HyperFlex™ Bunion Correction System
Applicant
Footbridge Medical
520 Elliot St.
Charlotte,  NC  28202
Applicant Contact Robert Peterhans
Correspondent
MCRA, LLC
803 7th St., NW, 3rd Floor
Washington, Dc,  DC  20001
Correspondent Contact Michael Coladonato
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received07/09/2024
Decision Date 11/26/2024
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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