# Innosys Co., Ltd.

- Location (FDA's records): Uijeongbu-Si, KR
- FDA decisions: 5 (2023–2024): 5 510(k) clearances
- Names in FDA's records: Innosys Co., Ltd. (4); Innosys (1)
- Product codes: NKB (2), HSB (1), OVE (1), OLO (1)
- 510(k) review time since 2016: median 113 days, against 72 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 15 (1 its own); citations of its devices by later devices: 2 (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
- U&I Corporation: 9 (https://510kreport.com/company/u-i)
- U&I Corp., America: 1 (https://510kreport.com/company/u-i-america)
- Interpore Cross Intl.: 1 (https://510kreport.com/company/interpore-cross-intl)
- Dio Medical Co., Ltd.: 1 (https://510kreport.com/company/dio-medical)
- Edisoninno Co., Ltd.: 1 (https://510kreport.com/company/edisoninno)
- Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic)

## Firms that cite its devices most
- Cg Medtech Co., Ltd.: 1 (https://510kreport.com/company/cg-medtech)

## Its most-cited devices
- K231737: ANAX™ 5.5 Spinal System (2023), cited by 1
- K234119: UniSpace® Stand-Alone C Cage (2024), cited by 1

## Recent decisions
- K241082: INNOVERSE Navigation Instruments (Jun 14, 2024)
- K234119: UniSpace® Stand-Alone C Cage (Apr 19, 2024)
- K233960: INNOVERSE Spinal System (Feb 6, 2024)
- K231737: ANAX™ 5.5 Spinal System (Oct 26, 2023)
- K221084: Dyna Locking Trochanteric Nail™ (Mar 3, 2023)

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