Ibalance Medical, Inc.
Country not established
- Devices
- 1
What Ibalance Medical, Inc. makes
Ibalance Medical, Inc. manufactures orthopedic implants and surgical instrumentation for lower limb reconstruction, including medial opening wedge tibial systems, PEEK (polyether ether ketone) implants, and associated fixation anchors.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Ibalance Akrfx Medial Opening Wedge Tibial System, Ifx Medial Peek Implant And Anchor, Akrfx Instrumentation Ref K092381
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ibalance Medical, Inc. have in the registry?
The registry currently lists 1 device for Ibalance Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ibalance Medical, Inc.'s devices?
Among its 1 most recently registered device, Ibalance Medical, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Ibalance Medical, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Ibalance Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ibalance Medical, Inc. in the registry?
The most recently registered devices listed for Ibalance Medical, Inc. include IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION.