K253991

Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA

510(k) number: K253991
Device name: Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA
Applicant: Orthofix Srl IT
Product code: HSB — Rod, Fixation, Intramedullary And Accessories
Decision date: 2026-05-08
Date received: 2025-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Orthopedic

Also available from FDA: K253991.pdf

Official FDA record: K253991

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.