# Imedicom Co., Ltd.

- Location (FDA's records): Gunpo-Si, KR
- FDA decisions: 7 (2014–2019): 7 510(k) clearances
- Names in FDA's records: Imedicom Co., Ltd. (6); Imedicom (1)
- Product codes: HRX (2), BSO (2), NDN (2), GEI (1)
- 510(k) review time since 2016: median 308 days, against 108 for FDA's reviews in the same codes and years (0 of 5 faster)
- Predicates its devices cite: 10 (1 its own); citations of its devices by later devices: 7 (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
- Kyphon, Inc.: 3 (https://510kreport.com/company/kyphon)
- Myelotec, Inc.: 2 (https://510kreport.com/company/myelotec)
- Medic Evaluation Devices & Instruments Corp.: 1 (https://510kreport.com/company/medic-evaluation-devices-instruments)
- Arthrocare Corp.: 1 (https://510kreport.com/company/arthrocare)
- U&I Corporation: 1 (https://510kreport.com/company/u-i)
- Ebi, L.P.: 1 (https://510kreport.com/company/ebi)

## Firms that cite its devices most
- GS Medical Co., Ltd.: 2 (https://510kreport.com/company/gs-medical)
- Ningbo Hicren Biotechnology Co., Ltd.: 1 (https://510kreport.com/company/ningbo-hicren-biotechnology)
- Hanchang Co., Ltd.: 1 (https://510kreport.com/company/hanchang)
- Jmt Co., Ltd.: 1 (https://510kreport.com/company/jmt)
- Taeyeon Medical Co., Ltd.: 1 (https://510kreport.com/company/taeyeon-medical)

## Its most-cited devices
- K153296: MEDINAUT Kyphoplasty System (2016), cited by 3
- K133669: Medinaut Kyphoplasty System (2014), cited by 3
- K150789: Spinaut-E, Spinaut-I (2016), cited by 1

## Recent decisions
- K182287: MEDINAUT Plus (Apr 6, 2019)
- K173541: Epinaut (Aug 24, 2018)
- K153296: MEDINAUT Kyphoplasty System (Jul 29, 2016)
- K150915: Spinaut-P (Mar 18, 2016)
- K151268: Spinaut-V, Spinaut-S, Spinaut-I (Mar 16, 2016)
- K150789: Spinaut-E, Spinaut-I (Mar 1, 2016)
- K133669: Medinaut Kyphoplasty System (Apr 4, 2014)

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