# Paonan Biotech Co., Ltd.

- Location (FDA's records): Taipei, TW
- FDA decisions: 6 (2017–2023): 6 510(k) clearances
- Product codes: MAX (2), NKB (2), ODP (1), KTW (1)
- 510(k) review time since 2016: median 364 days, against 131 for FDA's reviews in the same codes and years (0 of 5 faster)
- Predicates its devices cite: 26 (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
- Stryker Corp.: 5 (https://510kreport.com/company/stryker)
- Depuy Spine, Inc.: 2 (https://510kreport.com/company/depuy-spine)
- Showa Ika Kohgyo Co., Ltd.: 2 (https://510kreport.com/company/showa-ika-kohgyo)
- Orthofix, Inc.: 2 (https://510kreport.com/company/orthofix)
- Ortho Development Corp.: 2 (https://510kreport.com/company/ortho-development)
- Depuy, Inc.: 2 (https://510kreport.com/company/depuy)
- Depuyacromed: 2 (https://510kreport.com/company/depuyacromed)
- Spineart: 1 (https://510kreport.com/company/spineart)

## Firms that cite its devices most
- Biogend Therapeutics Co., Ltd.: 1 (https://510kreport.com/company/biogend-therapeutics)
- S.H.Pitkar Orthotools Pvt., Ltd.: 1 (https://510kreport.com/company/shpitkar-orthotools-pvt)

## Its most-cited devices
- K180230: NEST Interbody System (2019), cited by 1
- K180226: TREND II Spinal Fixation System- STEP Series (2018), cited by 1
- K180228: II-Type Intervertebral Spacer (2019), cited by 1
- K161225: Paonan Armstrong Posterior Spinal Fixation System (2017), cited by 1

## Recent decisions
- K220261: NEST-C Interbody System (Apr 24, 2023)
- K182285: PK High Tibial Osteotomy Correction System (Jun 20, 2019)
- K180230: NEST Interbody System (Jan 25, 2019)
- K180228: II-Type Intervertebral Spacer (Jan 11, 2019)
- K180226: TREND II Spinal Fixation System- STEP Series (Jul 25, 2018)
- K161225: Paonan Armstrong Posterior Spinal Fixation System (Aug 11, 2017)

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