Data / Medical devices / Orthopedic Stereotaxic Instrument / Australia
FDA-registered makers of Orthopedic Stereotaxic Instrument in Australia: 6 establishments
6 establishments in Australia are registered with the FDA to make Orthopedic Stereotaxic Instrument (product code OLO). 3 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Orthopedic Stereotaxic Instrument
- Product code
- OLO
- Country
- Australia
Makers of Orthopedic Stereotaxic Instrument in Australia
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Kico Knee Innovation Company | Frenchs Forest New South Wales, Australia | Complaint file establishment, Manufacturer | 5 | August 8, 2024 | 0 | 1 | 0 | api.fda.gov |
| Gyder Surgical Pty Ltd | Mulgrave Victoria, Australia | Complaint file establishment, Exporter to the US, Specification developer | 1 | January 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| Navbit Pty Ltd | South Eveleigh New South Wales, Australia | Manufacturer | 1 | July 30, 2026 | 0 | 0 | 0 | api.fda.gov |
| Mac Surgical | Brookvale New South Wales, Australia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sabre Medical Pty Ltd | Lane Cove West New South Wales, Australia | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Srxglobal (australia) Pty Ltd | Dandenong Victoria, Australia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.