FDA device listing
Gamma4 System
FDA device listing 1441872674 · STRYKER CORP.
Key facts
| Proprietary names | Gamma4 System |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Premarket submissions | K213328 |
| Product codes | HSB, HWC |
| Device names | HSB - Rod, Fixation, Intramedullary And Accessories, HWC - Screw, Fixation, Bone |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3020, 888.3040 |
| Review panels | Orthopedic |
| Registered establishments | STRYKER GmbH, STRYKER LEIBINGER GMBH & CO. KG, STRYKER TRAUMA GMBH |
| Establishment registrations | 8010177, 8031020, 9610622 |
| FEI numbers | 3002807231, 3002807830, 3002821504 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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