FDA device listing
INFINITY,K2M General Instruments,Restoration Modular Trials,Stryker Orthopaedics Templates,Stryker Orthopaedics…
FDA device listing 1569771303 · STRYKER CORP.
Key facts
| Proprietary names | INFINITY,K2M General Instruments,Restoration Modular Trials,Stryker Orthopaedics Templates,Stryker Orthopaedics Trials,Tornier Radial Head System,Triathlon MSI Trials,Vikos Allograft System,Xia Blocker Inserter,XIA Rod Template |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Product codes | HWT |
| Device names | HWT - Template |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4800 |
| Review panels | Orthopedic |
| Registered establishments | HOWMEDICA OSTEONICS CORP, SERF, STRYKER GmbH, STRYKER IRELAND OSTEONICS, STRYKER LEIBINGER GMBH & CO. KG, TORNIER Inc., TORNIER, INC., Tornier S.A.S., WRIGHT MEDICAL TECHNOLOGY, INC. |
| Establishment registrations | 1043534, 1649390, 2249697, 8010177, 8031020, 9616680, 3000931034, 3004983210, 3008668801, 3010667733 |
| FEI numbers | 1043534, 3000718467, 3000931034, 3002459190, 3002807830, 3002821504, 3003070421, 3004983210, 3008668801, 3010667733 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| 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