K231715
- 510(k) number
- K231715
- Device name
- MONDRIAN Anterior Lumbar Plate System
- Applicant
- Ctl Medical Corporation TX · US
- Product code
- KWQ — Appliance, Fixation, Spinal Intervertebral Body
- Decision date
- 2024-01-26
- Date received
- 2023-06-13
- 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: K231715.pdf
Official FDA record: K231715
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.