Data / Medical devices / Australia / Actis Medical
Actis Medical: FDA-registered device maker in Torrensville South Australia, Australia, 1 510(k) clearance
Actis Medical is registered with the FDA (registration 3034532468) in Torrensville South Australia, Australia. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 10, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3034532468
- Address
- Unit 3/18 Ashwin Parade, Torrensville South Australia, Australia, 5031
- Owner or operator
- ACTIS MEDICAL (10092149)
- Roles
- Manufacturer
- First device listed
- December 9, 2024
- Registered through
- 2026
- Brand names listed
- A3 Access Drill Kit - Manual Orthopedic Instruments, Inner Passer, Smart Osteotomy, Spade Tip Drill / Drill Bit, Surgical Director
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Passer | HWQ | 1 | Manufacturer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Manufacturer | accessdata.fda.gov |
| Probe And Director, Gastro-Urology | FGM | 1 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 10, 2026 | K260090 | SMART Osteotomy System | HRS | Substantially Equivalent | Actis Medical Pty., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Bit, Drill
- All makers of Passer
- All makers of Probe And Director, Gastro-Urology
- All makers of Screw, Fixation, Bone
- All makers of Plate, Fixation, Bone
- All makers of Orthopedic Manual Surgical Instrument
Updated April 10, 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.