FDA device listing
ACM,AEQUALIS PERFORM,AUTOPLEX,MIXER,MIXEVAC CEMENT MIXERS AND KITS,PCD,REVOLUTION
FDA device listing 1715998030 · STRYKER CORP.
Key facts
| Proprietary names | ACM,AEQUALIS PERFORM,AUTOPLEX,MIXER,MIXEVAC CEMENT MIXERS AND KITS,PCD,REVOLUTION |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Product codes | JDZ |
| Device names | JDZ - Mixer, Cement, For Clinical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4210 |
| Review panels | Orthopedic |
| Registered establishments | Stryker Instruments, STRYKER MANUFACTURING KALAMAZOO, STRYKER PUERTO RICO, LLC., Stryker Tijuana Operations, Stryker US Supply Chain Operations, Tornier S.A.S. |
| Establishment registrations | 2648666, 3000931034, 3007997036, 3012497308, 3015967359, 3020163307 |
| FEI numbers | 2648666, 3000931034, 3007997036, 3012497308, 3015967359, 3020163307 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, Contract Manufacturer, 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