Flexco Medical Instruments
SwitzerlandFDA applicant, unverified
- Devices
- 1
What Flexco Medical Instruments makes
Flexco Medical Instruments manufactures The Hayek Oscillator, a surgical device used for oscillating bone cuts during orthopedic procedures, particularly in spinal and limb surgeries.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance for market authorisation. The manufacturer is based in the United States.
Catalogue
The Hayek Oscillator Ref K903745
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Flexco Medical Instruments have in the registry?
The registry currently lists 1 device for Flexco Medical Instruments. Devices recorded under merged duplicate company entries are counted once.
Which registries list Flexco Medical Instruments's devices?
Among its 1 most recently registered device, Flexco Medical Instruments has devices listed in FDA 510(k) (1 device).
What risk classes do Flexco Medical Instruments's devices fall under?
Among its 1 most recently registered device, the classes recorded for Flexco Medical Instruments's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Flexco Medical Instruments in the registry?
The most recently registered devices listed for Flexco Medical Instruments include THE HAYEK OSCILLATOR.