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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 K221621
Device Name Pro-X1™ Trochanteric Nailing System
Applicant
X-Bolt Orthopedics
Unit 5 Northwood Court
Santry,  IE 9
Applicant Contact Brian Thornes
Correspondent
MCRA, LLC
803 7th St., NW, 3rd Floor
Washington, Dc,  DC  20001
Correspondent Contact Hollace Saas Rhodes
Regulation Number888.3020
Classification Product Code
HSB  
Date Received06/03/2022
Decision Date 03/06/2023
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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