FDA device listing
ZS 601-034-4724 Ped Prb2 3mm w/Ortho TRDRP Imp,ZS 601-038-3 BacFix Pedicle Probe Shaft 3MM Straight Quick Release,ZS…
FDA device listing 1148184439 · Banister Tool, Inc.
Key facts
| Proprietary names | ZS 601-034-4724 Ped Prb2 3mm w/Ortho TRDRP Imp,ZS 601-038-3 BacFix Pedicle Probe Shaft 3MM Straight Quick Release,ZS 601-038-4C Pedicle Probe Shaft 4MM Curved (Quick Release),ZS 601-097-L Removable Probe Tip (Left),ZS 601-097-R Removable Probe Tip (Right) |
|---|---|
| Owner/operator | Banister Tool, Inc. |
| Owner/operator number | 10042616 |
| Product codes | HXB |
| Device names | HXB - Probe |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | BANISTER TOOL, INC. |
| Establishment registrations | 1649379 |
| FEI numbers | 3000718490 |
| Establishment operations | Contract 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