Kens Finemedtech Sdn. Bhd
MalaysiaFDA applicant, unverified
- Devices
- 1
What Kens Finemedtech Sdn. Bhd makes
Kens Finemedtech Sdn. Bhd manufactures the KENS Internal Fixation System, a medical device designed for orthopedic applications to stabilize bone fractures through internal fixation techniques.
The company’s portfolio is regulated under Class II devices in the US and is listed in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
Kens Internal Fixation System Ref K090786
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Kens Finemedtech Sdn. Bhd have in the registry?
The registry currently lists 1 device for Kens Finemedtech Sdn. Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kens Finemedtech Sdn. Bhd's devices?
Among its 1 most recently registered device, Kens Finemedtech Sdn. Bhd has devices listed in FDA 510(k) (1 device).
What risk classes do Kens Finemedtech Sdn. Bhd's devices fall under?
Among its 1 most recently registered device, the classes recorded for Kens Finemedtech Sdn. Bhd's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kens Finemedtech Sdn. Bhd in the registry?
The most recently registered devices listed for Kens Finemedtech Sdn. Bhd include KENS INTERNAL FIXATION SYSTEM.