FDA device listing
ACM CARTRIDGE & TIPs,ALIQUOT DELIVERY SYSTEM,Cement Pusher,DUALSPEED CEMENT INJECTION GUN,DUAL SPEED INJECTION…
FDA device listing 1980643301 · STRYKER CORP.
Key facts
| Proprietary names | ACM CARTRIDGE & TIPs,ALIQUOT DELIVERY SYSTEM,Cement Pusher,DUALSPEED CEMENT INJECTION GUN,DUAL SPEED INJECTION GUN,Friction Cement Gun,Injector Transfer Tube,LATE INJECTION CEMENT GUN,PERCUTANEOUS CEMENT GUN,Revolution Cement Gun,REVOLUTION TIPS,STRYKER CEMENT INJECTOR,Syringe |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Product codes | KIH |
| Device names | KIH - Dispenser, Cement |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4200 |
| Review panels | Orthopedic |
| Registered establishments | HOWMEDICA INTERNATIONAL S. DE R.L.,, Stryker Instruments, STRYKER PUERTO RICO, LLC., WRIGHT MEDICAL TECHNOLOGY, INC. |
| Establishment registrations | 2648666, 9610726, 3010667733, 3015967359 |
| FEI numbers | 2648666, 3002807172, 3010667733, 3015967359 |
| Establishment operations | Complaint File Establishment, Specification Developer, Manufacturer |
| 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