FDA Device Establishments · JSON-LD · Markdown
FEI 3009540749 · Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3009540749 |
|---|---|
| Owner / Operator | MEDARTIS AG (#9033581) |
| Address | 1195 Polk Drive, Warsaw, IN, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 1 |
| Product codes (top 20) | LXH |
| Regulation § (21 CFR) | 888.4540 |
| Proprietary names | APTUS and MODUS Instruments; Lapidus Cut Guide; StealthFix Intraosseous Fixation System; Lapiprep Lapidus Preparation System; Patella Clamp Head; PSN Drop Rod Adapter; BandLoc; PediFlex; PediFrag; Avenger Radial Head System |
Source: openFDA. Public-domain (CC0).