Binder Biomedical, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Binder Biomedical, Inc. makes
Binder Biomedical, Inc. manufactures intervertebral body fusion devices, including standalone implants designed for spinal stabilization procedures. These products are intended for use in surgical interventions to address degenerative disc disease or spinal instability by promoting fusion between vertebrae.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) clearance registry, and the manufacturer operates from the United States.
Catalogue
Binder Intervertebral Body Fusion Device Ref K093015
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Binder Biomedical, Inc. have in the registry?
The registry currently lists 2 devices for Binder Biomedical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Binder Biomedical, Inc.'s devices?
Among its 2 most recently registered devices, Binder Biomedical, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Binder Biomedical, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Binder Biomedical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Binder Biomedical, Inc. in the registry?
The most recently registered devices listed for Binder Biomedical, Inc. include BINDER INTERVERTEBRAL BODY FUSION DEVICE and LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE.