FDA Device Establishments · JSON-LD · Markdown
FEI 3012523063 · Manufacture Medical Device · Status: Active
| FEI Number | 3012523063 |
|---|---|
| Owner / Operator | implantcast GmbH (#10054139) |
| Address | Lueneburger Schanze 26, Buxtehude Lower Saxony, 21614, DE |
| Mandatory US Agent | IMPLANTCAST AMERICA, LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | LZO, KWY, OQI |
| Regulation § (21 CFR) | 888.3353, 888.3390 |
| Proprietary names | BethaLoc® stem cementless HA |
Source: openFDA. Public-domain (CC0).