FDA Device Establishments · JSON-LD · Markdown
FEI 3012429289 · Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device · Status: Active
| FEI Number | 3012429289 |
|---|---|
| Owner / Operator | Xenix Medical (#10051846) |
| Address | 149 W Michigan St, Orlando, FL, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | HWX |
| Regulation § (21 CFR) | 888.4540 |
| Proprietary names | RIVA Posterior Fixation System Cannulated Pedicle Tap, 11.5mm; RIVA Posterior Fixation System Cannulated Pedicle Tap, 10.5mm; RIVA Posterior Fixation System Awl-Tip Iliac Tap, 7.5mm; RIVA Posterior Fixation System Cannulated Pedicle Tap, 12.5mm; RIVA Posterior Fixation System Pedicle Tap, 11.5mm; RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 4.5mm; RIVA Posterior Fixation System Iliac Tap, 10.5mm; RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 10.5mm; RIVA Posterior Fixation System Awl-Tip Pedicle Tap, 7.5mm; RIVA Posterior Fixation System Cannulated Iliac Tap, 11.5mm |
Source: openFDA. Public-domain (CC0).