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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 K241815
Device Name Protean Fragment Plating System
Applicant
Skeletal Dynamics, Inc.
7300 N. Kendall Dr.
Suite 800
Miami,  FL  33156
Applicant Contact Alexandra Rodriguez Rojas
Correspondent
Skeletal Dynamics, Inc.
7300 N. Kendall Dr.
Suite 800
Miami,  FL  33156
Correspondent Contact Alexandra Rodriguez Rojas
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received06/24/2024
Decision Date 09/26/2024
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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