FDA device listing
BIOSURE DRIVER 5MM,BIOSURE REGENESORB,BIOSURE REGEN SCREW 5 X 20MM,SCREW BIOSURE REGENESORB 10MM X 20MM,SCREW BIOSURE…
FDA device listing 1060550478 · Smith & Nephew, Inc.
Key facts
| Proprietary names | BIOSURE DRIVER 5MM,BIOSURE REGENESORB,BIOSURE REGEN SCREW 5 X 20MM,SCREW BIOSURE REGENESORB 10MM X 20MM,SCREW BIOSURE REGENESORB 10MM X 25MM,SCREW BIOSURE REGENESORB 10MM X 30MM,SCREW BIOSURE REGENESORB 10MM X 35MM,SCREW BIOSURE REGENESORB 11MM X 25MM,SCREW BIOSURE REGENESORB 11MM X 30MM,SCREW BIOSURE REGENESORB 11MM X 35MM,SCREW BIOSURE REGENESORB 12MM X 35MM,SCREW BIOSURE REGENESORB 5MM X… |
|---|---|
| Owner/operator | Smith & Nephew, Inc. |
| Owner/operator number | 1020279 |
| Premarket submissions | K142948 |
| Product codes | MAI |
| Device names | MAI - Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3030 |
| Review panels | Orthopedic |
| Registered establishments | SMITH & NEPHEW INC. |
| Establishment registrations | 1219602, 3003604053 |
| FEI numbers | 1219602, 3003604053 |
| Establishment operations | Manufacturer, Specification Developer |
| 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