Medacta Inernational SA
SwitzerlandFDA applicant, unverified
- Devices
- 4
What Medacta Inernational SA makes
Medacta International SA manufactures orthopedic implants and surgical guidance tools, including transforaminal interbody fusion cages made from TiPEEK, pedicle screw placement guides for spinal fixation, lateralized glenospheres for shoulder arthroplasty, and a platform for navigation-assisted total knee arthroplasty (TKA).
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
MectaLIF Transforaminal TiPEEK Ref K200551
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Lateralized Glenosphere Ref K193175
Regimes: 510(k) Registry: 510(k)NextAR TKA Platform Ref K193559
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medacta Inernational SA have in the registry?
The registry currently lists 4 devices for Medacta Inernational SA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medacta Inernational SA's devices?
Among its 4 most recently registered devices, Medacta Inernational SA has devices listed in FDA 510(k) (4 devices).
What risk classes do Medacta Inernational SA's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Medacta Inernational SA's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medacta Inernational SA in the registry?
The most recently registered devices listed for Medacta Inernational SA include MectaLIF Transforaminal TiPEEK, MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides, Lateralized Glenosphere and NextAR TKA Platform.