Orthopaedic Innovations, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Orthopaedic Innovations, Inc. makes
Orthopaedic Innovations, Inc. manufactures cemented hip implants, including femoral stems, acetabular cups, and modular endo heads, as well as external fixation systems like the Cobra External Fixator and Practifix External Fixation System. Their portfolio also includes femoral cement plugs and calcar femoral stems designed for orthopaedic procedures.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. Products are intended for use in the United States, where the manufacturer is based.
Catalogue
Prime Cemented Hip System Ref K940328
Regimes: 510(k) Registry: 510(k)Cobra External Fixator Ref K983881
Regimes: 510(k) Registry: 510(k)Practifix External Fixation System Ref K960014
Regimes: 510(k) Registry: 510(k)Prime Femoral Cement Plug Ref K955751
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Prime Cemented Calcar Femoral Stems Ref K955620
Regimes: 510(k) Registry: 510(k)Prime Cemented Small Femoral Stem Ref K953033
Regimes: 510(k) Registry: 510(k)Prime Modular Endo Head Ref K962646
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Orthopaedic Innovations, Inc. have in the registry?
The registry currently lists 8 devices for Orthopaedic Innovations, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orthopaedic Innovations, Inc.'s devices?
Among its 8 most recently registered devices, Orthopaedic Innovations, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Orthopaedic Innovations, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Orthopaedic Innovations, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orthopaedic Innovations, Inc. in the registry?
The most recently registered devices listed for Orthopaedic Innovations, Inc. include PRIME CEMENTED HIP SYSTEM, COBRA EXTERNAL FIXATOR, PRACTIFIX EXTERNAL FIXATION SYSTEM and PRIME FEMORAL CEMENT PLUG.