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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 K181640
Device Name X-BOLT Hip Fracture Fixation System
Applicant
X-Bolt Orthopaedics
Unit 5 Northwood Ct. Santry, Dublin 9
Dublin,  IE
Applicant Contact Brian Thornes
Correspondent
Musculoskeletal Clinical Regulatory Advisers, LLC
Unit 5, Northwood Ct.
Dublin,  IE
Correspondent Contact Brian Thornes
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
KTT  
Date Received06/21/2018
Decision Date 10/12/2018
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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