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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K253325
Device Name ZipToe™ Hammertoe Fusion System
Applicant
Toetal Solutions
7 Great Valley Pkwy.
Suite 295
Malvern,  PA  19355
Applicant Contact Bill Rhoda
Correspondent
MRC Global, LLC
9085 E. Mineral Cir., Suite 110
Centennial,,  CO  80112
Correspondent Contact Danielle Besal
Regulation Number888.3040
Classification Product Code
HTY  
Date Received09/30/2025
Decision Date 12/29/2025
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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