Expanding Orthopedics, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Expanding Orthopedics, Inc. makes
Expanding Orthopedics, Inc. manufactures spinal fixation devices, including the EOI Spinal System and the FLXFIT Intervertebral Body Fusion Device, designed for surgical stabilization of the spine. These products are intended for use in spinal fusion procedures to support and align vertebrae.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) clearance pathway. The devices are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Eoi Spinal System Ref K083825
510(k) 510(k)Flxfit Intervertebral Body Fusion Device Ref K133813
510(k) 510(k)FLXfit™ Ref K171519
510(k) 510(k)
Frequently asked questions
How many devices does Expanding Orthopedics, Inc. have in the registry?
The registry currently lists 3 devices for Expanding Orthopedics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Expanding Orthopedics, Inc.'s devices?
Among its 3 most recently registered devices, Expanding Orthopedics, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Expanding Orthopedics, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Expanding Orthopedics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Expanding Orthopedics, Inc. in the registry?
The most recently registered devices listed for Expanding Orthopedics, Inc. include EOI SPINAL SYSTEM, FLXFIT INTERVERTEBRAL BODY FUSION DEVICE and FLXfit™.