Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FITBONE® Transport and Lengthening System

K-Number: K232169 · 2024-03-22

ApplicantOrthofix Srl
Decision Date2024-03-22
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FITBONE® Transport and Lengthening System is a medical device manufactured by Orthofix Srl. It received FDA 510(k) clearance on 2024-03-22 under approval number K232169. 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® Transport and Lengthening System?

FITBONE® Transport and Lengthening System is a medical device that received FDA 510(k) clearance on 2024-03-22. It is manufactured by Orthofix Srl. The 510(k) number is K232169.

When was FITBONE® Transport and Lengthening System approved by the FDA?

FITBONE® Transport and Lengthening System received FDA 510(k) clearance on 2024-03-22, under approval number K232169.

What company makes FITBONE® Transport and Lengthening System?

FITBONE® Transport and Lengthening System is manufactured by Orthofix Srl.

What is the FDA product code for FITBONE® Transport and Lengthening System?

The FDA product code for FITBONE® Transport and Lengthening System is HSB.

Related Clinical Trials

NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT07581301 Administering Atropine Through Autoinjectors Within Ambulance Services for Poisoning Patients in Sri Lanka's North Central Province NOT_YET_RECRUITING NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING NCT04766684 Clubfoot Tenotomy Trial COMPLETED NCT07556588 XVIVO Heart Transplant Study in Clinical Practice RECRUITING NCT06485596 HOPE at Heart (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System. ACTIVE_NOT_RECRUITING

Other Devices by Orthofix Srl

K153233Galaxy UNYCO System K173458ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System K173051Orthofix MJ-FLEX THE NEW METAIZEAU NAIL K170146Galaxy UNYCO System K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0 K161466ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System

View all 23 devices →

Related Devices (Code: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

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.

↑