FDA Device Establishments · JSON-LD · Markdown
FEI 3022472578 · Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3022472578 |
|---|---|
| Owner / Operator | Surgical Fusion Inc. (#10084995) |
| Address | 930 Sylvan Ave, Suite 125, Englewood Cliffs, NJ, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 5 |
| Product codes (top 20) | NKB, HTY, HWC, GAT, MAI |
| Regulation § (21 CFR) | 888.3070, 888.3040, 878.5000, 888.3030 |
| Proprietary names | SF Push-in Anchor 1.6; Stopper S-PI-A2.3; Drill PI-S-A1.6; Guide S-PI / W5; Tray SF Push-in Anchor Portfolio; Drill PI-S-A2.3; SF Push-in Anchor 3; SupraFuser Ultrasonic Generator; Stopper S-PI-A1.6; SupraFuser Handpiece |
Source: openFDA. Public-domain (CC0).