FDA Device Establishments · JSON-LD · Markdown
FEI 3030400539 · Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3030400539 |
|---|---|
| Owner / Operator | Promethean Restorative (#10090289) |
| Address | 333 Perry St Ste 210, Castle Rock, CO, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LXH |
| Regulation § (21 CFR) | 888.4540 |
| Proprietary names | AUXOFUZE SI Delivery System; FUSIO SI Allograft System |
Source: openFDA. Public-domain (CC0).