# Corelink, LLC

- Location (FDA's records): St. Louis, MO
- FDA decisions: 35 (2008–2023): 35 510(k) clearances
- Product codes: OLO (7), NKB (6), KWQ (5), MAX (4), ODP (3), OUR (2), OVE (2), NKG (1), MQP (1), KWP (1), MNI (1), MNH (1)
- 510(k) review time since 2016: median 120 days, against 90 for FDA's reviews in the same codes and years (10 of 23 faster)
- Predicates its devices cite: 164 (47 its own); citations of its devices by later devices: 103 (47 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
- Depuy Spine, Inc.: 20 (https://510kreport.com/company/depuy-spine)
- Medtronic Sofamor Danek: 10 (https://510kreport.com/company/medtronic-sofamor-danek)
- Ebi, L.P.: 6 (https://510kreport.com/company/ebi)
- Globus Medical, Inc.: 5 (https://510kreport.com/company/globus-medical)
- Synthes (Usa): 4 (https://510kreport.com/company/synthes-usa)
- Synthes Spine: 4 (https://510kreport.com/company/synthes-spine)
- SI-BONE, Inc.: 3 (https://510kreport.com/company/si-bone)
- Orthofix, Inc.: 3 (https://510kreport.com/company/orthofix)

## Firms that cite its devices most
- Icotec AG: 5 (https://510kreport.com/company/icotec)
- Camber Spine Technologies: 3 (https://510kreport.com/company/camber-spine-technologies)
- Restor3D: 3 (https://510kreport.com/company/restor3d)
- Nexxt Spine, LLC: 2 (https://510kreport.com/company/nexxt-spine)
- B2b Spine Pty, Ltd.: 2 (https://510kreport.com/company/b2b-spine)
- Printerprezz: 2 (https://510kreport.com/company/printerprezz)
- Eminent Spine: 2 (https://510kreport.com/company/eminent-spine)
- Ortho Development Corp.: 2 (https://510kreport.com/company/ortho-development)

## Its most-cited devices
- K162496: Foundation 3D Interbody (2017), cited by 10
- K113058: Tiger Spine System (2012), cited by 9
- K133369: Tiger Spine System (2014), cited by 7
- K110321: Tiger Spine System (2011), cited by 6
- K180814: CoreLink® M3™ Stand-Alone Anterior Lumbar System (2018), cited by 6
- K073440: Foundation Cage (2008), cited by 5

## Recent decisions
- K231743: F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System (Dec 8, 2023)
- K231494: CoreLink Robotic Navigation Instruments (Oct 27, 2023)
- K232116: CoreLink Navigation Instruments (Aug 16, 2023)
- K230329: F3D Interbody System (Jun 6, 2023)
- K230880: CoreLink Navigation Instruments (May 2, 2023)
- K223708: Entasis 3D Dual-Lead Sacroiliac Implant System (Mar 21, 2023)
- K221776: NextGen Pedicle Screw System (Aug 9, 2022)
- K220973: CoreLink Navigation Instruments (Jun 1, 2022)

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