Biodynamik, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Biodynamik, Inc. makes
Biodynamik, Inc. manufactures the XT3 System, including variants such as the Mini and 40mm configurations, designed for orthopedic applications in spinal and extremity procedures.
The company’s portfolio is regulated under FDA 510(k) clearance as Class II devices and is listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
XT3 System Ref K241357
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biodynamik, Inc. have in the registry?
The registry currently lists 2 devices for Biodynamik, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biodynamik, Inc.'s devices?
Among its 2 most recently registered devices, Biodynamik, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Biodynamik, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Biodynamik, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biodynamik, Inc. in the registry?
The most recently registered devices listed for Biodynamik, Inc. include XT3 System and XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm.