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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K250867
Device Name Dunamis Screw and Suture Locking System
Applicant
Dunamis Medical, LLC
104 Camellia Ave. Suite B
Greenville,  AL  36037
Applicant Contact PrithviRaj Chavan
Correspondent
Mcra, LLC
803 7th St. NW, 3rd Floor
Washington,  DC  20001
Correspondent Contact Sarah Pleaugh
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
GAT   MBI  
Date Received03/24/2025
Decision Date 08/15/2025
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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