FDA device listing
10.0MM FLEXIBLE REAMER,10.5MM FLEXIBLE REAMER,11.0MM FLEXIBLE REAMER,11.5MM FLEXIBLE REAMER,12.0MM FLEXIBLE REAMER,4.5MM…
FDA device listing 1960414692 · STRYKER CORP.
Key facts
| Proprietary names | 10.0MM FLEXIBLE REAMER,10.5MM FLEXIBLE REAMER,11.0MM FLEXIBLE REAMER,11.5MM FLEXIBLE REAMER,12.0MM FLEXIBLE REAMER,4.5MM FLEXIBLE REAMER,5.0MM FLEXIBLE REAMER,5.5MM FLEXIBLE REAMER,6.0MM FLEXIBLE REAMER,6.5MM FLEXIBLE REAMER,7.0MM FLEXIBLE REAMER,7.5MM FLEXIBLE REAMER,8.0MM FLEXIBLE REAMER,8.5MM FLEXIBLE REAMER,9.0MM FLEXIBLE REAMER,9.5MM FLEXIBLE REAMER,AEQUALIS REVERSED,BIT,FLEXIBLE GUIDE… |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Product codes | GFG |
| Device names | GFG - Bit, Surgical |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4820 |
| Review panels | General & Plastic Surgery |
| Registered establishments | STRYKER ENDOSCOPY, Stryker Instruments, STRYKER IRELAND LTD., INSTRUMENTS DIVISION, Stryker Ireland Ltd. Instruments Division, Innovation Centre, TORNIER Inc., TORNIER, INC., Tornier S.A.S., WRIGHT MEDICAL TECHNOLOGY, INC. |
| Establishment registrations | 1043534, 1649390, 2936485, 9616696, 3000931034, 3004983210, 3010667733, 3015967359, 3040335671 |
| FEI numbers | 1043534, 2936485, 3000718467, 3000931034, 3003164255, 3004983210, 3010667733, 3015967359, 3040335671 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, Contract Manufacturer |
| 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