Data / Medical devices / Australia / Polynovo Biomaterials Pty Ltd
Polynovo Biomaterials Pty Ltd: FDA-registered device maker in Port Melbourne Victoria, Australia, 3 510(k) clearances
Polynovo Biomaterials Pty Ltd is registered with the FDA (registration 3007886187) in Port Melbourne Victoria, Australia. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated June 20, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007886187
- Address
- 2/320 lorimer Street, Port Melbourne Victoria, Australia, 3207
- Owner or operator
- PolyNovo Biomaterials Pty Ltd (10046720)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 22, 2023
- Registered through
- 2026
- Brand names listed
- NovoSorb MTX, NovoSorb® BTM, NovoSorb® SynPath
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorbable Synthetic Wound Dressing | QSZ | U | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| June 20, 2025 | K251567 | NovoSorb BTM | QSZ | Substantially Equivalent | Polynovo Biomaterials Pty, Ltd. | accessdata.fda.gov |
| March 5, 2025 | K242149 | NovoSorb® MTX | QSZ | Substantially Equivalent | Polynovo Biomaterials Pty, Ltd. | accessdata.fda.gov |
| September 15, 2022 | K221686 | NovoSorb Matrix | QSZ | Substantially Equivalent | Polynovo Biomaterials Pty, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 20, 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.