FDA device listing
AxSOS,AxSOS 3,Bioabsorable Wedge Interference Screw System,Biosteon IntraLine System,Biosteon Wedge Interference Screw…
FDA device listing 1238364649 · STRYKER CORP.
Key facts
| Proprietary names | AxSOS,AxSOS 3,Bioabsorable Wedge Interference Screw System,Biosteon IntraLine System,Biosteon Wedge Interference Screw System,General Instruments,MaxTorque, DRLock Extreme,OSTEONICS BONE TAP,Pangea Platform,PEEK IntraLine Anchor System,STRYKER COMBO PUNCH,TAP,Variable Angle Fixation |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Product codes | HWX |
| Device names | HWX - Tap, Bone |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | STRYKER ENDOSCOPY, STRYKER GmbH, STRYKER LEIBINGER GMBH & CO. KG, TORNIER Inc., TORNIER, INC., Tornier S.A.S., WRIGHT MEDICAL TECHNOLOGY, INC. |
| Establishment registrations | 1043534, 1649390, 2936485, 8010177, 8031020, 3000931034, 3004983210, 3010667733 |
| FEI numbers | 1043534, 2936485, 3000718467, 3000931034, 3002807830, 3002821504, 3004983210, 3010667733 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, Repackager/Relabeler |
| 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