FDA device listing
3.9mm Omega Drill,4.75mm AlphaVent and Omega Drill,5.5mm AlphaVent and 4.75mm Hard Bone Omega Drill,ACL…
FDA device listing 1503847797 · STRYKER CORP.
Key facts
| Proprietary names | 3.9mm Omega Drill,4.75mm AlphaVent and Omega Drill,5.5mm AlphaVent and 4.75mm Hard Bone Omega Drill,ACL Workstation,BioZip System,CinchLock,Cross-Screw System,DRILL BIT,General Instruments,ICONIX All Suture Anchor System,Inter-Lock System,Knotilus+ 2.4x11.3mm Drill,Knotilus+ 2.4X11.3mm Drill, Hard Bone,Knotilus+ 2.4x8.9mm Drill, Hard Bone, Hip,Knotilus+ 2.4x8.9mm Drill, Hip,Knotilus+ 2.9x12.5mm… |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Product codes | HTW |
| Device names | HTW - Bit, Drill |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | Artelon, HOWMEDICA OSTEONICS CORP, INTERNATIONAL LIFE SCIENCES, STRYKER EMEA Supply Chain Services, STRYKER ENDOSCOPY, STRYKER GmbH, STRYKER IRELAND OSTEONICS, STRYKER LEIBINGER GMBH & CO. KG, Stryker Macroom, TORNIER Inc., TORNIER, INC., Tornier S.A.S. and 1 more |
| Establishment registrations | 1043534, 1649390, 2249697, 2936485, 8010177, 8031020, 9616680, 3000931034, 3004983210, 3008337808, 3008837339, 3010667733, 3010673515, 3033273526 |
| FEI numbers | 1043534, 2936485, 3000718467, 3000931034, 3002459190, 3002807830, 3002821504, 3003070421, 3004983210, 3008337808, 3008837339, 3010667733, 3010673515, 3033273526 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, Contract Manufacturer, Foreign Exporter |
| 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