K231743
- 510(k) number
- K231743
- Device name
- F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System
- Applicant
- Corelink, LLC MO · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2023-12-08
- Date received
- 2023-06-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K231743.pdf
Official FDA record: K231743
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.