FDA device listing
11 MM GRAFT SIZING TUBE,12 MM GRAFT SIZING TUBE,13 MM GRAFT SIZING TUBE,14 MM GRAFT SIZING TUBE,6 MM GRAFT SIZING…
FDA device listing 1209041312 · Smith & Nephew, Inc.
Key facts
| Proprietary names | 11 MM GRAFT SIZING TUBE,12 MM GRAFT SIZING TUBE,13 MM GRAFT SIZING TUBE,14 MM GRAFT SIZING TUBE,6 MM GRAFT SIZING TUBE,ACUFEX GRAFTMASTER III PREPARATION BOARD,ADVANSYS DLP,ADVANSYS MLP,ADVANSYS TTC,B-BOP,DRILL FLUTED 3.0MM WITH DEPTH STOP,ENDOBUTTON HOLDER SCALE EXTENDER,EVOS,GENESIS II,GRAFTMASTER ENDOBUTTON HOLDER,GRAFTMASTER II CUTTING STRIP,GRAFTMASTER II GRAFT PREP BRD.,GRAFTMASTER III BTB… |
|---|---|
| Owner/operator | Smith & Nephew, Inc. |
| Owner/operator number | 1020279 |
| Product codes | HWT |
| Device names | HWT - Template |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4800 |
| Review panels | Orthopedic |
| Registered establishments | Smith & Nephew, Inc., SMITH & NEPHEW INC., SMITH & NEPHEW, INC. |
| Establishment registrations | 1020279, 1219602, 1643264, 3003604053, 3007366790, 3038503932 |
| FEI numbers | 1020279, 1219602, 1643264, 3003604053, 3007282753, 3038503932 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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