FDA device listing
CRW,CRW-1 System,CRW Precision Arc Steriotactic System
FDA device listing 1827993708 · Integra LifeSciences Corporation
Key facts
| Proprietary names | CRW,CRW-1 System,CRW Precision Arc Steriotactic System |
|---|---|
| Owner/operator | Integra LifeSciences Corporation |
| Owner/operator number | 9004007 |
| Premarket submissions | K160811 |
| Product codes | HAW |
| Device names | HAW - Neurological Stereotaxic Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.4560 |
| Review panels | Neurology |
| Registered establishments | Integra LifeSciences Corporation, INTEGRA LIFESCIENCES CORPORATION, Integra Pain Management |
| Establishment registrations | 1722447, 3003418325, 3004608878 |
| FEI numbers | 1000138491, 3003418325, 3004608878 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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