Bioarchitects USA, LLC
Country not established
- Devices
- 1
What Bioarchitects USA, LLC makes
Bioarchitects USA, LLC manufactures patient-specific cranial and craniofacial plates designed for surgical reconstruction of skull defects. These devices are custom-fabricated using imaging data to match individual anatomical contours, supporting procedures for trauma, tumor resection, or congenital deformities.
The company’s products fall under FDA Class II regulation and are listed via the 510(k) pathway. The portfolio is authorised for use in the United States, where the manufacturer is based.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bioarchitects USA, LLC have in the registry?
The registry currently lists 1 device for Bioarchitects USA, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioarchitects USA, LLC's devices?
Among its 1 most recently registered device, Bioarchitects USA, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Bioarchitects USA, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Bioarchitects USA, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bioarchitects USA, LLC in the registry?
The most recently registered devices listed for Bioarchitects USA, LLC include BioArchitects Patient Specific Cranial/Craniofacial Plate.