Global Orthopaedic Technology, USA, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Global Orthopaedic Technology, USA, Inc. makes
Global Orthopaedic Technology, USA, Inc. manufactures unicompartmental knee resurfacing systems, including the GRU Knee and GRU Knee System, designed for partial knee replacement. Their portfolio also includes the RBK Patella Femoral Knee, a device intended for patellofemoral joint resurfacing. These products are tailored for targeted orthopaedic interventions in the knee joint.
The company’s devices fall under FDA Class II regulation and are authorised via the 510(k) clearance pathway. Their products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Global Resurfacing Unicompartmental (Gru) Knee Ref K033351
Regimes: 510(k) Registry: 510(k)Global Resurfacing Unicompartmental Knee System Ref K051721
Regimes: 510(k) Registry: 510(k)Rbk Patella Femoral Knee Ref K050473
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Global Orthopaedic Technology, USA, Inc. have in the registry?
The registry currently lists 3 devices for Global Orthopaedic Technology, USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Global Orthopaedic Technology, USA, Inc.'s devices?
Among its 3 most recently registered devices, Global Orthopaedic Technology, USA, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Global Orthopaedic Technology, USA, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Global Orthopaedic Technology, USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Global Orthopaedic Technology, USA, Inc. in the registry?
The most recently registered devices listed for Global Orthopaedic Technology, USA, Inc. include GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE, GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM and RBK PATELLA FEMORAL KNEE.