FDA device listing
2306 HOOK,2307 HOOK,2308 HOOK,BLADE CURVED MM F CUTC SINGLE PACK,BLADE MMFCUT SINGLE PACK,BLADES PLASTIC HOLDER UB…
FDA device listing 1211622787 · Meta Ergonomica S.r.l.
Key facts
| Proprietary names | 2306 HOOK,2307 HOOK,2308 HOOK,BLADE CURVED MM F CUTC SINGLE PACK,BLADE MMFCUT SINGLE PACK,BLADES PLASTIC HOLDER UB 31X82X11 TRANSP. PP 23,BLEXO-ARCH-PATHFINDERS,BLEXO-DISTAL-ANGLEFIT,BLEXO-LONGRT-PATHFINDERS,BLEXO-MESIAL-ANGLEFIT,BLEXO-MICRO-PATHFINDERS,BLEXOO-LEFTSIDE-ANGLEFIT,BLEXO-RIGHTSIDE-ANGLEFIT,BLEXO-SLIM-PATHFINDERS,CROWN REMOVER HANDPIECE,CROWN REMOVER HOOKS KIT,CROWN REMOVER… |
|---|---|
| Owner/operator | Meta Ergonomica S.r.l. |
| Owner/operator number | 10055830 |
| Product codes | KDG |
| Device names | KDG - Chisel (Osteotome) |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4820 |
| Review panels | General & Plastic Surgery |
| Registered establishments | META ERGONOMICA S.R.L. |
| Establishment registrations | 3011922183 |
| FEI numbers | 3011922183 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database