FDA Device Establishments · JSON-LD · Markdown
FEI 3025783933 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device · Status: Active
| FEI Number | 3025783933 |
|---|---|
| Owner / Operator | Gyder Surgical Us Inc. (#10093254) |
| Address | 30-32 Compark Circuit, Mulgrave Victoria, 3170, AU |
| Mandatory US Agent | Gyder Surgical US Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | OLO |
| Regulation § (21 CFR) | 882.4560 |
| Proprietary names | GYDER® Hip System |
Source: openFDA. Public-domain (CC0).