Dontech Products B.V.
NetherlandsFDA 510(k) applicant, unverified
- Devices
- 1
What Dontech Products B.V. makes
Dontech Products B.V. manufactures the T-GEAR (Model TG/400-700), a medical device designed for orthopedic applications, likely used in joint replacement or spinal surgery to secure implants or components.
The T-GEAR falls under FDA Class II regulation and is listed in the 510(k) clearance registry. The company is based in the United States.
Catalogue
T-Gear, Model Tg/400-700 Ref K993224
510(k) 510(k)
Frequently asked questions
How many devices does Dontech Products B.V. have in the registry?
The registry currently lists 1 device for Dontech Products B.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dontech Products B.V.'s devices?
Among its 1 most recently registered device, Dontech Products B.V. has devices listed in FDA 510(k) (1 device).
What risk classes do Dontech Products B.V.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Dontech Products B.V.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dontech Products B.V. in the registry?
The most recently registered devices listed for Dontech Products B.V. include T-GEAR, MODEL TG/400-700.