# Dio Medical Co., Ltd.

- Location (FDA's records): East Norriton, PA
- FDA decisions: 13 (2010–2023): 13 510(k) clearances
- Names in FDA's records: Dio Medical Co., Ltd. (7); Dio Medical Corporation (4); Dio Medical, Inc. (1); Dio Medical Corp. (1)
- Product codes: KWQ (2), ODP (2), PEK (2), OVE (1), MNH (1), MRW (1), NKB (1), KWP (1), MNI (1), OUR (1)
- 510(k) review time since 2016: median 77 days, against 103 for FDA's reviews in the same codes and years (6 of 8 faster)
- Predicates its devices cite: 19 (6 its own); citations of its devices by later devices: 39 (6 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
- Huvexel Co., Ltd.: 7 (https://510kreport.com/company/huvexel)
- Bm Korea Co., Ltd.: 1 (https://510kreport.com/company/bm-korea)
- U&I Corp., America: 1 (https://510kreport.com/company/u-i-america)
- U&I Corporation: 1 (https://510kreport.com/company/u-i)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)
- Solco Biomedical Co., Ltd.: 1 (https://510kreport.com/company/solco-biomedical)
- GS Medical Co., Ltd.: 1 (https://510kreport.com/company/gs-medical)

## Firms that cite its devices most
- K&J Consulting Corp.: 7 (https://510kreport.com/company/k-j-consulting)
- U&I Corporation: 7 (https://510kreport.com/company/u-i)
- Core-Nexus: 4 (https://510kreport.com/company/core-nexus)
- Accel Spine: 4 (https://510kreport.com/company/accel-spine)
- Huvexel Co., Ltd.: 3 (https://510kreport.com/company/huvexel)
- Tdm Co., Ltd.: 2 (https://510kreport.com/company/tdm)
- Medynus, Inc.: 2 (https://510kreport.com/company/medynus)
- Innosys Co., Ltd.: 1 (https://510kreport.com/company/innosys)

## Its most-cited devices
- K111362: Rexious Spinal Fixation System (2011), cited by 7
- K100765: Fixpine II System (2010), cited by 7
- K122872: Intervertebral Body Fusion Device (2013), cited by 6
- K162220: DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage (2016), cited by 4
- K121862: Rex Anterior Cervical Plate System (2012), cited by 4
- K113324: Rexious Hook Fixation Systems (2012), cited by 3

## Recent decisions
- K223790: Huvex Interspinous Fusion System (Mar 9, 2023)
- K223140: AEON-C™ Stand Alone System (Dec 20, 2022)
- K222415: Rexious Spinal Fixation System (Oct 25, 2022)
- K222572: FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System (Oct 18, 2022)
- K222448: UNITY Sacroiliac Joint Fixation System (Oct 13, 2022)
- K222515: FaSet Fixation System (Oct 5, 2022)
- K162849: Huvex Interspinous Fixation System (Feb 16, 2017)
- K162220: DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage (Nov 21, 2016)

Source page: https://510kreport.com/company/dio-medical