FDA Device Establishments · JSON-LD · Markdown
FEI 2183449 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 2183449 |
|---|---|
| Owner / Operator | Orthofix US LLC (#10028162) |
| Address | 3451 Plano Parkway, Lewisville, TX, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 3 |
| Product codes (top 20) | MQP, OVE, ODP |
| Regulation § (21 CFR) | 888.3060, 888.3080 |
| Proprietary names | CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM |
Source: openFDA. Public-domain (CC0).