FDA device listing
ADVANSYS,ADVANSYS TTC,Anatomic ACL Tray,ARTHROSCOPIC LATARJET/BONE BLOCK LID,ARTHROSCOPIC LATARJET/BONE BLOCK…
FDA device listing 1612799697 · Smith & Nephew, Inc.
Key facts
| Proprietary names | ADVANSYS,ADVANSYS TTC,Anatomic ACL Tray,ARTHROSCOPIC LATARJET/BONE BLOCK LID,ARTHROSCOPIC LATARJET/BONE BLOCK TRAY,A-Tech ACL Sterilization Tray,AUTOCLAVABLE ARTHROSCOPE STERILIZATION TRAY 9.5 INCH LENGTH X 3 INCH WIDTH X 1.25 INCH HEIGHT,Bilok Instrument Sterilization Tray,Chondral Pick Sterilization Tray,DPR SYSTEM,D-RAD,ECTRA HAND HOLDER/STERILIZATION TRAY WITH… |
|---|---|
| Owner/operator | Smith & Nephew, Inc. |
| Owner/operator number | 1020279 |
| Product codes | FSM |
| Device names | FSM - Tray, Surgical, Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Arthrocare Corporation, Smith & Nephew, Inc., SMITH & NEPHEW INC., SMITH & NEPHEW, INC., SMITH & NEPHEW ORTHOPAEDICS AG |
| Establishment registrations | 1020279, 1219602, 1643264, 9613369, 3003604053, 3007366790, 3012358417, 3038503932 |
| FEI numbers | 1020279, 1219602, 1643264, 3002807893, 3003604053, 3007282753, 3012358417, 3038503932 |
| Establishment operations | Manufacturer, Remanufacturer, Repackager/Relabeler, 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