Genesys Spine
United Statesfrom the FDA registration address FDA FEI 3008455034
- Devices
- 31
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Genesys Spine makes
Genesys Spine manufactures spinal fixation and fusion systems, including anterior and posterior plating solutions, interbody fusion cages, and sacroiliac joint fusion devices. Their portfolio includes cortical and lateral spinal systems, cervical and lumbar interbody implants, and modular plate systems designed for surgical stabilization of the spine. Products are engineered for use in degenerative disc disease, spinal deformity correction, and trauma-related spinal injuries.
All listed devices fall under Class II regulatory classification in the US and are authorised via 510(k) clearance through the FDA. The company’s products are registered under the FDA 510(k) pathway, ensuring compliance with US medical device regulations. The manufacturer is based in the United States.
Catalogue
Search and filter all 31 devicesCompany details
- FDA FEI number
- 3008455034
- Address
- 1250 S Capital of TX Highway, Austin, TX, 78746
Frequently asked questions
How many devices does Genesys Spine have in the registry?
The registry currently lists 31 devices for Genesys Spine. Devices recorded under merged duplicate company entries are counted once.
Which registries list Genesys Spine's devices?
Among its 31 most recently registered devices, Genesys Spine has devices listed in FDA 510(k) (31 devices).
What risk classes do Genesys Spine's devices fall under?
Among its 31 most recently registered devices, the classes recorded for Genesys Spine's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Genesys Spine in the registry?
The most recently registered devices listed for Genesys Spine include GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM, Genesys Spine Apache Interbody Fusion System, Genesys Spine TiLock Cortical Spinal System and Genesys Spine TiLock2 Spinal System.