Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 10 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Orthofix and its 4 subsidiaries with 229 510(k) clearances, 80 device recalls and 2 AI-enabled devices. The most recent is a 510(k) clearance dated Oct 9, 2026: CarboClear® Cervical Navigated Instruments.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Orthofix and its 4 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 9, 2026 | CarboClear® Cervical Navigated InstrumentsK263154 · OLO | 510(k) clearances |
| May 19, 2026 | FITBONE® TRANSPORT AND LENGTHENING SYSTEMK260146 · HSB | 510(k) clearances |
| May 8, 2026 | Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAK253991 · HSB | 510(k) clearances |
| Mar 16, 2026 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemK254045 · NKG | 510(k) clearances |
| Oct 31, 2025 | Firebird SI Navigation SystemK252088 · OLO | 510(k) clearances |
| Apr 10, 2025 | FitboneTM TrochantericK250112 · HSB | 510(k) clearances |
| Dec 19, 2024 | OrthoNext Platform SystemK242270 · QIH | 510(k) clearances |
| Dec 19, 2024 | OrthoNext Platform SystemK242270 · Radiology | AI-enabled devices |
| Dec 3, 2024 | TrueLok ElevateK242861 · KTT | 510(k) clearances |
| Sep 26, 2023 | OFIX MIS AppK230252 · Radiology | AI-enabled devices |
| May 21, 2014 | Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws ofClass II · Integra has identified through an investigation of complaints that there may be the potential for the tip of a single l | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
