Data / Medical devices / Australia / Orthocell Limited
Orthocell Limited: FDA-registered device maker in Perth Western Australia, Australia, 2 510(k) clearances
Orthocell Limited is registered with the FDA (registration 3014015147) in Perth Western Australia, Australia. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014015147
- Address
- Building 191 Murdoch University, South Street, Murdoch, Perth Western Australia, Australia, 6150
- Owner or operator
- Orthocell Limited (10081188)
- Roles
- Manufacturer
- First device listed
- March 23, 2021
- Registered through
- 2026
- Brand names listed
- Remplir, Striate+, perFORM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Barrier, Animal Source, Intraoral | NPL | 2 | Manufacturer | accessdata.fda.gov |
| Cuff, Nerve | JXI | 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 2, 2025 | K243889 | Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm) | JXI | Substantially Equivalent | Orthocell, Ltd. | accessdata.fda.gov |
| January 11, 2021 | K201241 | Striate+ | NPL | Substantially Equivalent | Orthocell, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 2, 2025. 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.