Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K260146
Device Name FITBONE® TRANSPORT AND LENGTHENING SYSTEM
Applicant
Orthofix Srl
Via Delle Nazioni, 9
Bussolengo (Vr),  IT 37012
Applicant Contact Elvira Taccarelli
Correspondent
Orthofix Srl
Via Delle Nazioni, 9
Bussolengo (Vr),  IT 37012
Correspondent Contact Chiara Zuliani
Regulation Number888.3020
Classification Product Code
HSB  
Date Received01/20/2026
Decision Date 05/19/2026
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
-
-