FDA device listing
ENDOBUTTON, 4.0 MM X 12 MM,Endobutton, sterile, non-sterile,MENISCAL ROOT REPAIR PACK WITH ULTRATAPE SUTURE,MENISCAL…
FDA device listing 2069635917 · Smith & Nephew, Inc.
Key facts
| Proprietary names | ENDOBUTTON, 4.0 MM X 12 MM,Endobutton, sterile, non-sterile,MENISCAL ROOT REPAIR PACK WITH ULTRATAPE SUTURE,MENISCAL ROOT REPAIR PACK W/ULTRABRAID |
|---|---|
| Owner/operator | Smith & Nephew, Inc. |
| Owner/operator number | 1020279 |
| Premarket submissions | K933948 |
| 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 | Arthrocare Corporation, Smith & Nephew, Inc., SMITH & NEPHEW INC. |
| Establishment registrations | 1219602, 1643264, 3003604053, 3012358417, 3038503932 |
| FEI numbers | 1219602, 1643264, 3003604053, 3012358417, 3038503932 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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