FDA device listing
Zimmer 10403-2144 ACP 2 LVL SPKLESS HYBRID PLATE,ZS 403-4072 ACP 4 Lvl Spiked Plate 72mm
FDA device listing 1287704579 · Banister Tool, Inc.
Key facts
| Proprietary names | Zimmer 10403-2144 ACP 2 LVL SPKLESS HYBRID PLATE,ZS 403-4072 ACP 4 Lvl Spiked Plate 72mm |
|---|---|
| Owner/operator | Banister Tool, Inc. |
| Owner/operator number | 10042616 |
| Product codes | KWQ |
| Device names | KWQ - Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3060 |
| 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