FDA device listing
ANTEVERSION GUIDE,Cut Guide,DRILL GUIDE,Drill Guide Non Sterile,DRILL SLEEVE,FUNNEL,Glenoid pin guide,Instrument…
FDA device listing 1630892575 · STRYKER CORP.
Key facts
| Proprietary names | ANTEVERSION GUIDE,Cut Guide,DRILL GUIDE,Drill Guide Non Sterile,DRILL SLEEVE,FUNNEL,Glenoid pin guide,Instrument Guides,Knotilus+ Crown Tip Guide,Knotilus+ Crown Tip Guide, Hip,Knotilus+ Fishmouth Tip Guide,Knotilus+ Fork Tip Guide, Hip,Knotilus+ Offset Tip Guide,NEEDLE GUIDE,OSTEONICS,RESECTION GUIDE,STERNUM SAW REPLACEMENT GUIDE,T2 Guide Wire Ball Tip,Tornier Extraction,VariAx 2, Drill… |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Product codes | FZX |
| Device names | FZX - Guide, Surgical, Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | HOWMEDICA OSTEONICS CORP, STRYKER EMEA Supply Chain Services, STRYKER ENDOSCOPY, STRYKER GmbH, STRYKER IRELAND OSTEONICS, STRYKER LEIBINGER GMBH & CO. KG, Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd., Stryker (Suzhou) Medical Technology Co.,Ltd., STRYKER TRAUMA GMBH, TORNIER Inc., TORNIER, INC., Tornier S.A.S. and 1 more |
| Establishment registrations | 1043534, 1649390, 2249697, 2936485, 8010177, 8031020, 9610622, 9616680, 3000931034, 3004983210, 3005596372, 3007913880, 3008837339, 3010667733 |
| FEI numbers | 1043534, 2936485, 3000718467, 3000931034, 3002459190, 3002807231, 3002807830, 3002821504, 3003070421, 3004983210, 3005596372, 3007913880, 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