Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA
K-Number: K253991 · 2026-05-08
ApplicantOrthofix Srl
Decision Date2026-05-08
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA is a medical device manufactured by Orthofix Srl. It received FDA 510(k) clearance on 2026-05-08 under approval number K253991. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA?
Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA is a medical device that received FDA 510(k) clearance on 2026-05-08. It is manufactured by Orthofix Srl. The 510(k) number is K253991.
When was Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA approved by the FDA?
Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA received FDA 510(k) clearance on 2026-05-08, under approval number K253991.
What company makes Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA?
Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA is manufactured by Orthofix Srl.
What is the FDA product code for Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA?
The FDA product code for Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA is HSB.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.