FDA Device Establishments · JSON-LD · Markdown
FEI 4224 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 4224 |
|---|---|
| Owner / Operator | INSTITUT STRAUMANN AG (#9005052) |
| Address | 2237, AVENUE ANDRE LASQUIN, SALLANCHES Haute-Savoie, 74700, FR |
| Mandatory US Agent | Straumann USA, LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | MAX |
| Regulation § (21 CFR) | 888.3080 |
| Proprietary names | ROI Interbody Fusion System |
Source: openFDA. Public-domain (CC0).