Data / Medical devices / Australia / Navbit Pty Ltd
Navbit Pty Ltd: FDA-registered device maker in South Eveleigh New South Wales, Australia, 2 510(k) clearances
Navbit Pty Ltd is registered with the FDA (registration 3016075969) in South Eveleigh New South Wales, Australia. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 30, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016075969
- Address
- Suite 201, National Innovation Centre 4 Cornwallis Street, South Eveleigh New South Wales, Australia, 2015
- Owner or operator
- Navbit Pty Ltd (10080903)
- Roles
- Manufacturer
- First device listed
- August 5, 2026
- Registered through
- 2026
- Brand names listed
- Navbit Marq, Navbit Rapid Surgical Plan
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| July 30, 2026 | K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) | OLO | Substantially Equivalent | Suite 201, National Innovation Centre | accessdata.fda.gov |
| December 5, 2024 | K243447 | Rapid Surgical Plan (RSP-SW-001) | LLZ | Substantially Equivalent | Navbit Pty, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 30, 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.