FDA device listing
AMBI,ARO Osteotomy Guide Assembly,ARO Spacer Plate,DART SUTURE PASSER,DISTRACTOR WARUPA DOUBLE 1.1MM&1.6MM,DRILL GUIDE…
FDA device listing 1669556387 · Smith & Nephew, Inc.
Key facts
| Proprietary names | AMBI,ARO Osteotomy Guide Assembly,ARO Spacer Plate,DART SUTURE PASSER,DISTRACTOR WARUPA DOUBLE 1.1MM&1.6MM,DRILL GUIDE PHALANGEAL EXTRA ARTICULAR,DRILL GUIDE PHALANGEAL LONG OFFSET,DRILL GUIDE PHALANGEAL SHORT OFFSET,DRIVER CANNULATED SCREW,DRIVER PIP MIDDLE PHALANX,DRIVER PIP PROXIMAL PHALANX,DRIVER PIP PROXIMAL PHALANX 10 DEGREE,ELEVATOR COTTLE,ENGAGE,Forefoot II,GENESIS II,Guide,GUIDE… |
|---|---|
| Owner/operator | Smith & Nephew, Inc. |
| Owner/operator number | 1020279 |
| Product codes | FZX |
| Device names | FZX - Guide, Surgical, Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| 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