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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 K240530
Device Name DynaNail Mini Tapered Hybrid
Applicant
MedShape, Inc.
1575 Northside Dr.
Suite 440
Atlanta,  GA  30318
Applicant Contact Amberlee Soto
Correspondent
MedShape, Inc.
1575 Northside Dr.
Suite 440
Atlanta,  GA  30318
Correspondent Contact Amberlee Soto
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
JDS  
Date Received02/23/2024
Decision Date 03/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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