# Bioarchitects USA, LLC

- Location (FDA's records): New York, NY
- FDA decisions: 1 (2015–2015): 1 510(k) clearance
- Product codes: GXN (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)

## Firms that cite its devices most
- CG Bio Co., Ltd.: 1 (https://510kreport.com/company/cg-bio)
- The Surgeon General, Department of the Army (TSG-DA): 1 (https://510kreport.com/company/surgeon-general-department-of-the-army-tsg-da)

## Its most-cited devices
- K151692: BioArchitects Patient Specific Cranial/Craniofacial Plate (2015), cited by 2

## Recent decisions
- K151692: BioArchitects Patient Specific Cranial/Craniofacial Plate (Nov 20, 2015)

Source page: https://510kreport.com/company/bioarchitects-usa