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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K253291
Device Name Excelsior System
Applicant
Blue Ocean Global
12550 Biscayne Blvd.
Suite 110
Miami,  FL  33181
Applicant Contact Scott Ludecker
Correspondent
MEDIcept, Inc.
200 Homer Ave.,
Ashland,  MA  01721
Correspondent Contact Danielle Short
Regulation Number888.3030
Classification Product Code
KTT  
Date Received09/29/2025
Decision Date 01/20/2026
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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