Data / Medical devices / Australia / Gyder Surgical Pty Ltd
Gyder Surgical Pty Ltd: FDA-registered device maker in Mulgrave Victoria, Australia, 1 510(k) clearance
Gyder Surgical Pty Ltd is registered with the FDA (registration 3025783933) in Mulgrave Victoria, Australia. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 29, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025783933
- Address
- 30-32 Compark Circuit, Mulgrave Victoria, Australia, 3170
- Owner or operator
- Gyder Surgical Us Inc. (10093254)
- Roles
- Complaint file establishment, Exporter to the US, Specification developer
- First device listed
- April 19, 2025
- Registered through
- 2026
- Brand names listed
- GYDER® Hip System, OCT AA Impactor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Impactor | HWA | 1 | Exporter to the US | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Complaint file establishment, Exporter to the US, Specification developer | 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 |
|---|---|---|---|---|---|---|
| January 29, 2025 | K243387 | GYDER® Hip System | OLO | Substantially Equivalent | Gyder Surgical Pty, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 29, 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.