K231494
- 510(k) number
- K231494
- Device name
- CoreLink Robotic Navigation Instruments
- Applicant
- Corelink, LLC MO · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2023-10-27
- Date received
- 2023-05-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K231494.pdf
Official FDA record: K231494
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.