Biotechni America Spine Group, Inc.
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- Devices
- 1
What Biotechni America Spine Group, Inc. makes
Biotechni America Spine Group, Inc. manufactures the SOLAS ANATOMIX SPINAL SYSTEM, a spinal fixation device designed for surgical stabilization of the spine. The system includes components for internal fixation, such as screws and rods, tailored for anatomical alignment during spinal procedures.
The SOLAS ANATOMIX SPINAL SYSTEM is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Solas Anatomix Spinal System Ref K083178
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biotechni America Spine Group, Inc. have in the registry?
The registry currently lists 1 device for Biotechni America Spine Group, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biotechni America Spine Group, Inc.'s devices?
Among its 1 most recently registered device, Biotechni America Spine Group, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Biotechni America Spine Group, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Biotechni America Spine Group, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biotechni America Spine Group, Inc. in the registry?
The most recently registered devices listed for Biotechni America Spine Group, Inc. include SOLAS ANATOMIX SPINAL SYSTEM.