FDA Device Establishments · JSON-LD · Markdown
FEI 3043534478 · 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 Manufacture Medical Device · Status: Active
| FEI Number | 3043534478 |
|---|---|
| Owner / Operator | Amber Implants (#10094065) |
| Address | Prinses Beatrixlaan 546, 2595 BM, The Hague, The Hague Zuid-Holland, 2595BM, NL |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | NDN |
| Regulation § (21 CFR) | 888.3027 |
| Proprietary names | VCFix® spinal system |
Source: openFDA. Public-domain (CC0).