FDA device listing
Lateral retractor access kit,Lateral retractor kit 120mm,Lateral retractor kit 140mm,Lateral retractor kit 160mm,Lateral…
FDA device listing 1530845784 · Neo Medical S.A.
Key facts
| Proprietary names | Lateral retractor access kit,Lateral retractor kit 120mm,Lateral retractor kit 140mm,Lateral retractor kit 160mm,Lateral retractor kit 180mm,MIS Posterior retractor access kit,MIS Posterior retractor kit 40mm,MIS Posterior retractor kit 50mm,MIS Posterior retractor kit 60mm,MIS Posterior retractor kit 70mm,MIS Posterior retractor kit 80mm,MIS Posterior retractor lateral blade kit 40mm,MIS… |
|---|---|
| Owner/operator | Neo Medical S.A. |
| Owner/operator number | 10054814 |
| Product codes | GAD |
| Device names | GAD - Retractor |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | NEO MEDICAL S.A. |
| Establishment registrations | 3013546462 |
| FEI numbers | 3013546462 |
| Establishment operations | Specification Developer |
| 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