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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 K252997
Device Name HyperFlex® Bunion Correction System
Applicant
Hyperflex Medical
2929 Lapeer Rd.
Port Huron,  MI  48060
Applicant Contact Robert Peterhans
Correspondent
MCRA
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Dave McGurl
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received09/18/2025
Decision Date 12/11/2025
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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