Stryker Ireland Ltd., Instruments Division
IrelandFDA applicant, unverified FDA FEI 3003164255
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Stryker Ireland Ltd., Instruments Division makes
Stryker Ireland Ltd., Instruments Division manufactures orthopedic surgical instruments, including the ESSX Microdebrider System—a powered device for joint tissue preparation—and disposable cranial perforator bits for bone drilling procedures.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Stryker Essx Microdebrider System Ref K073633
Regimes: 510(k) Registry: 510(k)Stryker Disposable Cranial Perforator Bit Ref K082010
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3003164255
- Address
- CARRIGTWOHILL BUSINESS &, CARRIGTWOHILL, CO.CORK Munster
Frequently asked questions
How many devices does Stryker Ireland Ltd., Instruments Division have in the registry?
The registry currently lists 2 devices for Stryker Ireland Ltd., Instruments Division. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stryker Ireland Ltd., Instruments Division's devices?
Among its 2 most recently registered devices, Stryker Ireland Ltd., Instruments Division has devices listed in FDA 510(k) (2 devices).
What risk classes do Stryker Ireland Ltd., Instruments Division's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Stryker Ireland Ltd., Instruments Division's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Stryker Ireland Ltd., Instruments Division in the registry?
The most recently registered devices listed for Stryker Ireland Ltd., Instruments Division include STRYKER ESSX MICRODEBRIDER SYSTEM and STRYKER DISPOSABLE CRANIAL PERFORATOR BIT.