Black Box Medical
Country not established
- Devices
- 3
What Black Box Medical makes
Black Box Medical manufactures orthopedic pedicle screw systems, including the Stowe and FUSE Pedicle Screw Systems, designed for spinal fixation and stabilization procedures.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Pedicle Screw System Ref K201751
Regimes: 510(k) Registry: 510(k)Stowe Pedicle Screw System Ref K181554
Regimes: 510(k) Registry: 510(k)FUSE Pedicle Screw System Ref K182283
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Black Box Medical have in the registry?
The registry currently lists 3 devices for Black Box Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Black Box Medical's devices?
Among its 3 most recently registered devices, Black Box Medical has devices listed in FDA 510(k) (3 devices).
What risk classes do Black Box Medical's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Black Box Medical's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Black Box Medical in the registry?
The most recently registered devices listed for Black Box Medical include Pedicle Screw System, Stowe Pedicle Screw System and FUSE Pedicle Screw System.