FDA device listing
Aequalis Fracture,Aequalis Reversed Fracture,Aequalis Reversed II,ALEUTIAN Interbody Systems Trays,Aluminum Lid…
FDA device listing 1860049516 · STRYKER CORP.
Key facts
| Proprietary names | Aequalis Fracture,Aequalis Reversed Fracture,Aequalis Reversed II,ALEUTIAN Interbody Systems Trays,Aluminum Lid - Universal,ATP Disc Prep,CANYON Retractor Systems Trays,CAPRI Corpectomy Cage System Trays,Cascadia Interbody System,CASPIAN Spinal System Trays,CAYMAN Plate System Trays,CHESAPEAKE Stabilization System Trays,DENALI Spinal System Trays,Eikon LT SL Sterilization Tray,Eikon LT… |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| 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 | HOWMEDICA OSTEONICS CORP, MAKO SURGICAL CORP., SERF, STRYKER ENDOSCOPY, STRYKER GmbH, Stryker Instruments, STRYKER IRELAND OSTEONICS, STRYKER LEIBINGER GMBH & CO. KG, STRYKER TRAUMA GMBH, TORNIER, INC., Tornier S.A.S., WRIGHT MEDICAL TECHNOLOGY, INC. |
| Establishment registrations | 1043534, 1649390, 2249697, 2936485, 8010177, 8031020, 9610622, 9616680, 3000931034, 3008668801, 3010667733, 3015967359, 3017410889 |
| FEI numbers | 1043534, 2936485, 3000718467, 3000931034, 3002459190, 3002807231, 3002807830, 3002821504, 3003070421, 3005985723, 3008668801, 3010667733, 3015967359 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 10–99 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