# Medynus, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 3 (2021–2022): 3 510(k) clearances
- Product codes: ODP (1), KWQ (1), NKB (1)
- 510(k) review time since 2016: median 22 days, against 85 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 7 (0 its own); citations of its devices by later devices: 1 (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
- Dio Medical Co., Ltd.: 2 (https://510kreport.com/company/dio-medical)
- Huvexel Co., Ltd.: 2 (https://510kreport.com/company/huvexel)
- Globus Medical, Inc.: 2 (https://510kreport.com/company/globus-medical)
- CG Bio Co., Ltd.: 1 (https://510kreport.com/company/cg-bio)

## Firms that cite its devices most
- MANTIZ Co., Ltd.: 1 (https://510kreport.com/company/mantiz)

## Its most-cited devices
- K210420: Goblin and Goblin LS Pedicle Screw Systems (2021), cited by 1

## Recent decisions
- K220379: IMPEACE and IMPEACE-Uni Anterior Cervical Plate System (Mar 3, 2022)
- K212792: Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage (Sep 23, 2021)
- K210420: Goblin and Goblin LS Pedicle Screw Systems (Apr 19, 2021)

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