# Huvexel Co., Ltd.

- Location (FDA's records): Seongnam-Si, KR
- FDA decisions: 8 (2017–2022): 8 510(k) clearances
- Product codes: KWQ (3), MAX (1), NKB (1), OVE (1), MRW (1), OUR (1)
- 510(k) review time since 2016: median 70 days, against 82 for FDA's reviews in the same codes and years (3 of 7 faster)
- Predicates its devices cite: 31 (1 its own); citations of its devices by later devices: 14 (1 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
- Globus Medical, Inc.: 11 (https://510kreport.com/company/globus-medical)
- Dio Medical Co., Ltd.: 3 (https://510kreport.com/company/dio-medical)
- Synthes (Usa): 3 (https://510kreport.com/company/synthes-usa)
- Nuvasive, Inc.: 2 (https://510kreport.com/company/nuvasive)
- Spinal Elements, Inc.: 2 (https://510kreport.com/company/spinal-elements)
- Medtronic Sofamor Danek: 2 (https://510kreport.com/company/medtronic-sofamor-danek)
- Synthes Spine: 1 (https://510kreport.com/company/synthes-spine)
- Ebi, L.P.: 1 (https://510kreport.com/company/ebi)

## Firms that cite its devices most
- Dio Medical Co., Ltd.: 7 (https://510kreport.com/company/dio-medical)
- Medynus, Inc.: 2 (https://510kreport.com/company/medynus)
- Spinecraft, LLC: 1 (https://510kreport.com/company/spinecraft)
- Neurostructures, Inc.: 1 (https://510kreport.com/company/neurostructures)
- Evolution Spine: 1 (https://510kreport.com/company/evolution-spine)
- Tdm Co., Ltd.: 1 (https://510kreport.com/company/tdm)

## Its most-cited devices
- K173131: Rexious Spinal Fixation System (2017), cited by 3
- K173099: Fortis and Hana Anterior Cervical Plate System (2017), cited by 2
- K173080: IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) (2017), cited by 2
- K200846: Balteum™ Lumbar Plate System (2020), cited by 2
- K191477: AEON-C Stand Alone System (2019), cited by 2
- K213820: BALTEUM - ONE™ Lumbar Plate System (2022), cited by 1

## Recent decisions
- K213820: BALTEUM - ONE™ Lumbar Plate System (Mar 25, 2022)
- K200846: Balteum™ Lumbar Plate System (May 5, 2020)
- K191477: AEON-C Stand Alone System (Nov 13, 2019)
- K180729: FaSet Fixation System (Jun 28, 2018)
- K173201: UNITY Sacroiliac Joint Fixation System (Apr 26, 2018)
- K173131: Rexious Spinal Fixation System (Dec 8, 2017)
- K173099: Fortis and Hana Anterior Cervical Plate System (Nov 30, 2017)
- K173080: IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) (Oct 31, 2017)

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