Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Orthonovis with 5 510(k) clearances. The most recent is a 510(k) clearance dated Oct 2, 2025: Cannulated Screw and Kirschner (K wire) System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 2, 2025 | Cannulated Screw and Kirschner (K wire) SystemK252758 · HWC | 510(k) clearances |
| Mar 17, 2025 | BPS Wrist Fracture SystemK250498 · HRS | 510(k) clearances |
| Feb 6, 2025 | BPS - Bone Fragment Fixation Plates, Screws and WashersK250055 · HRS | 510(k) clearances |
| Oct 4, 2024 | BPS Wrist Fracture SystemK242343 · HRS | 510(k) clearances |
| Aug 25, 2022 | ONX Large External Fixation SystemK213905 · KTT | 510(k) clearances |
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
