CoreLink Navigation Instruments— 510(k) K232116

Clearance details

Applicant

Corelink, LLC

Product code

Code OLO

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2023-07-17

Decision date

2023-08-16

Decision

Substantially Equivalent

Clearance type

Special

Location

St. Louis, MO, US

• K262506 — Remex Spine Surgery Navigation - Universal Instruments2026-08-20
• K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))2026-07-30
• K261205 — SPINEART Navigation Instrument System2026-07-29
• K261024 — TMINI Miniature Robotic System2026-07-24
• K262121 — Ion-L Navigated Instruments2026-07-24

• K231743 — F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System2023-12-08
• K231494 — CoreLink Robotic Navigation Instruments2023-10-27
• K230329 — F3D Interbody System2023-06-06
• K230880 — CoreLink Navigation Instruments2023-05-02
• K223708 — Entasis 3D Dual-Lead Sacroiliac Implant System2023-03-21

Death

11

Injury

2,799

Malfunction

11,105

Other

1

Total

13,916

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →