Data / Medical devices / Orthopedic Manual Surgical Instrument / Australia
FDA-registered makers of Orthopedic Manual Surgical Instrument in Australia: 7 establishments
7 establishments in Australia are registered with the FDA to make Orthopedic Manual Surgical Instrument (product code LXH). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Orthopedic Manual Surgical Instrument
- Product code
- LXH
- Country
- Australia
Makers of Orthopedic Manual Surgical Instrument in Australia
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Actis Medical | Torrensville South Australia, Australia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Field Orthopaedics | Teneriffe Queensland, Australia | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mac Surgical | Brookvale New South Wales, Australia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Optimized Ortho Pty Ltd | Sydney New South Wales, Australia | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osseointegration International Pty Ltd | Macquarie Park New South Wales, Australia | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Relax Retractors | Kingswood New South Wales, Australia | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Signature Orthopaedics Pty Limited | Sydney New South Wales, Australia | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.