FDA device listing
ACL Reconstruction Accessories,Bioabsorable Wedge Interference Screw System,Biosteon Wedge Interference Screw…
FDA device listing 1844583934 · STRYKER CORP.
Key facts
| Proprietary names | ACL Reconstruction Accessories,Bioabsorable Wedge Interference Screw System,Biosteon Wedge Interference Screw System,CalcLock Extreme,Cross-Screw System,DRIVER; SCREW INSERTER,DRLock Extreme,General Instruments,HexStar,Intraosseous Fixation System,MaxLock Extreme,MaxTorque,Mini MaxLock,Mini MaxTorque,Mini Variable,ORTHOPEDIC SCREWDRIVER,OSTEONICS,Screwdriver,SET SCREWDRIVER,STRYKER AUTOMATIC… |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Product codes | HXX |
| Device names | HXX - Screwdriver |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | STRYKER EMEA Supply Chain Services, STRYKER ENDOSCOPY, STRYKER GmbH, STRYKER LEIBINGER GMBH & CO. KG, Stryker Macroom, STRYKER TRAUMA GMBH, TORNIER Inc., TORNIER, INC., Tornier S.A.S., WRIGHT MEDICAL TECHNOLOGY, INC. |
| Establishment registrations | 1043534, 1649390, 2936485, 8010177, 8031020, 9610622, 3000931034, 3004983210, 3008337808, 3008837339, 3010667733 |
| FEI numbers | 1043534, 2936485, 3000718467, 3000931034, 3002807231, 3002807830, 3002821504, 3004983210, 3008337808, 3008837339, 3010667733 |
| 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