# U&I Corporation

- Location (FDA's records): Uijeongbu-Si, KR
- FDA decisions: 35 (2005–2022): 35 510(k) clearances
- Names in FDA's records: U&I Corporation (23); U&I Corp. (12)
- Product codes: KWQ (7), MNH (6), ODP (4), HSB (3), MAX (3), NKB (2), OVE (2), NKG (2), MRW (1), PEK (1), HWC (1), GEI (1)
- 510(k) review time since 2016: median 41 days, against 93 for FDA's reviews in the same codes and years (8 of 15 faster)
- Predicates its devices cite: 113 (29 its own); citations of its devices by later devices: 78 (29 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 8 (https://510kreport.com/company/synthes-usa)
- Medtronic Sofamor Danek: 8 (https://510kreport.com/company/medtronic-sofamor-danek)
- Dio Medical Co., Ltd.: 7 (https://510kreport.com/company/dio-medical)
- Arthrocare Corp.: 4 (https://510kreport.com/company/arthrocare)
- Biomet, Inc.: 4 (https://510kreport.com/company/biomet)
- U&I Corp., America: 4 (https://510kreport.com/company/u-i-america)
- Howmedica Corp.: 3 (https://510kreport.com/company/howmedica)
- Howmedica Osteonics Corp.: 3 (https://510kreport.com/company/howmedica-osteonics)

## Firms that cite its devices most
- Innosys Co., Ltd.: 9 (https://510kreport.com/company/innosys)
- L&K BIOMED Co., Ltd.: 6 (https://510kreport.com/company/l-k-biomed)
- Cg Medtech Co., Ltd.: 3 (https://510kreport.com/company/cg-medtech)
- Edisoninno Co., Ltd.: 2 (https://510kreport.com/company/edisoninno)
- Ldr Spine USA: 2 (https://510kreport.com/company/ldr-spine-usa)
- G Surgical, LLC: 2 (https://510kreport.com/company/g-surgical)
- Paragon 28, Inc.: 2 (https://510kreport.com/company/paragon-28)
- Allure Spine LLC: 1 (https://510kreport.com/company/allure-spine)

## Its most-cited devices
- K051971: Optima Spinal System (2005), cited by 18
- K132101: Anax 5.5 Spinal System (2013), cited by 7
- K061002: Maxima Anterior Cervical Plate System (2006), cited by 6
- K132926: Velofixtm Interbody Fusion System (2014), cited by 4
- K091725: Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549) (2009), cited by 4
- K143417: ANAX 5.5 Spinal System (2015), cited by 4

## Recent decisions
- K220147: Aspiron S ACP System (Feb 16, 2022)
- K210573: Velofix SA Cervical Cage (Nov 19, 2021)
- K183243: Velofix TLIF Cage (Jul 10, 2019)
- K190067: Velofix Interbody Fusion System (Feb 4, 2019)
- K190053: SECULOK™ ACP System (Feb 1, 2019)
- K181824: CBT Screw Fixation System (Dec 13, 2018)
- K183383: ANAX™ OCT Spinal System (Dec 12, 2018)
- K181829: Velofix TLIF Cage (Nov 14, 2018)

Source page: https://510kreport.com/company/u-i