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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K250628
Device Name DynaNail TTC Fusion System
Applicant
MedShape, Inc.
1575 Northside Dr. NW
Suite 440
Atlanta,  GA  30318
Applicant Contact Amberlee Soto
Correspondent
MedShape, Inc.
1575 Northside Dr. NW
Suite 440
Atlanta,  GA  30318
Correspondent Contact Vladislava Zaitseva
Regulation Number888.3020
Classification Product Code
HSB  
Date Received03/03/2025
Decision Date 09/12/2025
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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