# Baui Biotech Co., Ltd.

- Location (FDA's records): New Taipei City, TW
- FDA decisions: 5 (2017–2024): 5 510(k) clearances
- Product codes: NKB (4), MAX (1)
- 510(k) review time since 2016: median 266 days, against 84 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 4 (2 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
- Orthofix, Inc.: 1 (https://510kreport.com/company/orthofix)
- Synthes Spine: 1 (https://510kreport.com/company/synthes-spine)
- Sofamor Danek USA,Inc.: 1 (https://510kreport.com/company/sofamor-danek-usa)

## Firms that cite its devices most
- Orion Biotech, Inc.: 1 (https://510kreport.com/company/orion-biotech)
- Chanpin Medtak Co., Ltd.: 1 (https://510kreport.com/company/chanpin-medtak)

## Its most-cited devices
- K182416: NOVA Minimally Invasive System (2019), cited by 2
- K161231: Facilis™ Spinal System (2017), cited by 2

## Recent decisions
- K242899: NOVA Minimally Invasive System (Oct 17, 2024)
- K191353: COMET Lumbar Interbody Fusion Cage (Apr 14, 2020)
- K191494: Facilis™ Spinal System (Aug 12, 2019)
- K182416: NOVA Minimally Invasive System (Jun 11, 2019)
- K161231: Facilis™ Spinal System (Jan 23, 2017)

Source page: https://510kreport.com/company/baui-biotech