FDA Device Establishments · JSON-LD · Markdown
FEI 3014976005 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 3014976005 |
|---|---|
| Owner / Operator | OrthoXel (#10058878) |
| Address | Cube House, Cork Business and Technology Park, Model Farm Road, Bishopstown, Cork, T12 H966, IE |
| Mandatory US Agent | MCRA, LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | HTJ |
| Regulation § (21 CFR) | 888.4300 |
| Proprietary names | Apex Nailing System Instrumentation |
Source: openFDA. Public-domain (CC0).