Bio-Technology USA, Inc.
Country not established
- Devices
- 1
What Bio-Technology USA, Inc. makes
Bio-Technology USA, Inc. manufactures the MAX-FACE Maxillofacial Osteosynthesis System, a device used for internal fixation of facial bone fractures and reconstructive procedures in maxillofacial surgery.
The MAX-FACE system is classified as a Class II medical device in the US and is subject to 510(k) clearance through the FDA regulatory pathway. The company is based in the United States.
Catalogue
Max-Face Maxillofacial Osteosynthesis System Ref K073307
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bio-Technology USA, Inc. have in the registry?
The registry currently lists 1 device for Bio-Technology USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio-Technology USA, Inc.'s devices?
Among its 1 most recently registered device, Bio-Technology USA, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Bio-Technology USA, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Bio-Technology USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bio-Technology USA, Inc. in the registry?
The most recently registered devices listed for Bio-Technology USA, Inc. include MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM.