# Solco Biomedical Co., Ltd.

- Location (FDA's records): Rockville, MD
- FDA decisions: 17 (2005–2024): 17 510(k) clearances
- Product codes: MNH (6), NKB (3), MNI (2), MAX (2), ODP (2), HRS (1), KWQ (1)
- 510(k) review time since 2016: median 174 days, against 88 for FDA's reviews in the same codes and years (0 of 7 faster)
- Predicates its devices cite: 41 (8 its own); citations of its devices by later devices: 31 (8 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 Corp., America: 7 (https://510kreport.com/company/u-i-america)
- D.K.M. Co., Ltd.: 5 (https://510kreport.com/company/dkm)
- Synthes (Usa): 3 (https://510kreport.com/company/synthes-usa)
- Globus Medical, Inc.: 3 (https://510kreport.com/company/globus-medical)
- Spineart: 2 (https://510kreport.com/company/spineart)
- Depuy Spine, Inc.: 2 (https://510kreport.com/company/depuy-spine)
- Titan Spine, LLC: 1 (https://510kreport.com/company/titan-spine)
- Us Spine: 1 (https://510kreport.com/company/us-spine)

## Firms that cite its devices most
- L&K BIOMED Co., Ltd.: 9 (https://510kreport.com/company/l-k-biomed)
- Solco Biomedical Company India Private Limited: 2 (https://510kreport.com/company/solco-biomedical-company-india-private)
- S.H.Pitkar Orthotools Pvt., Ltd.: 2 (https://510kreport.com/company/shpitkar-orthotools-pvt)
- Korea Bone Bank Co., Ltd.: 1 (https://510kreport.com/company/korea-bone-bank)
- Jeil Medical Corporation: 1 (https://510kreport.com/company/jeil-medical)
- CG Bio Co., Ltd.: 1 (https://510kreport.com/company/cg-bio)
- Implanova Co., Ltd.: 1 (https://510kreport.com/company/implanova)
- Bk Meditech, Co., Ltd.: 1 (https://510kreport.com/company/bk-meditech)

## Its most-cited devices
- K092162: 4CIS Peek, Plif and Tlif Cage System (2010), cited by 6
- K060702: 4CIS Vane Spine System (2006), cited by 6
- K190471: 4CIS® Chiron Spinal Fixation System (2019), cited by 3
- K081145: Modification to 4CIS Vane Spine System (2008), cited by 2
- K050471: 4CIS Solar Spine System and 4CIS Apollon Spine System (2005), cited by 2
- K082453: 4CIS Solar and Apollon Spine Systems (2008), cited by 2

## Recent decisions
- K231655: 4CIS® Chiron Spinal Fixation System (Nov 26, 2024)
- K203233: 4CIS Chiron Spinal Fixation System (Jun 1, 2022)
- K192044: 4CIS Marlin PEEK ACIF Cage (Dec 19, 2019)
- K190563: 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage (Sep 18, 2019)
- K190471: 4CIS® Chiron Spinal Fixation System (Jul 24, 2019)
- K182489: 4CIS® Pinehurst Anterior Cervical Plate system (Jan 16, 2019)
- K162402: 4CIS® Marlin ACIF Cage System (Feb 16, 2017)
- K121615: 4CIS Vane Spine System (Aug 15, 2012)

Source page: https://510kreport.com/company/solco-biomedical