# Wiltrom Corporation Limited

- Location (FDA's records): Zhubei City, TW
- FDA decisions: 5 (2012–2020): 5 510(k) clearances
- Product codes: MQV (3), NKB (2)
- 510(k) review time since 2016: median 167 days, against 96 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 3 (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
- Biomatlante: 2 (https://510kreport.com/company/biomatlante)
- X-Spine Systems, Inc.: 1 (https://510kreport.com/company/x-spine-systems)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)

## Firms that cite its devices most
- Acro Biomedical Co., Ltd.: 1 (https://510kreport.com/company/acro-biomedical)

## Its most-cited devices
- K110949: Bicera (TM) Resorbable Bone Substitute (2012), cited by 2
- K172548: Wiltrom Spinal Fixation System (2018), cited by 1

## Recent decisions
- K202894: Wiltrom Spinal Fixation System (Oct 23, 2020)
- K180758: Osteocera Resorbable Bone Substitute (Oct 24, 2018)
- K172237: Bicera Resorbable Bone Substitute (Feb 2, 2018)
- K172548: Wiltrom Spinal Fixation System (Jan 12, 2018)
- K110949: Bicera (TM) Resorbable Bone Substitute (Sep 18, 2012)

Source page: https://510kreport.com/company/wiltrom