FDA device listing
Facial Tissue,Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade
FDA device listing 1095318588 · STRYKER CORP.
Key facts
| Proprietary names | Facial Tissue,Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 10094242 |
| Premarket submissions | K151387 |
| Product codes | DMG, HBW |
| Device names | DMG - Papers, Ion, HBW - Fastener, Plate, Cranioplasty |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.2230, 882.5360 |
| Review panels | Clinical Chemistry, Neurology |
| Registered establishments | QUANZHOU APEX HYGIENE PRODUCTS CO.,LTD, STRYKER LEIBINGER GMBH & CO. KG |
| Establishment registrations | 8010177, 3016816754 |
| FEI numbers | 3002821504, 3016816754 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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