K231920
- 510(k) number
- K231920
- Device name
- Longeviti ClearFit OTS Cranial Implant
- Applicant
- Longeviti Neuro Solutions, LLC MD · US
- Product code
- GXN — Plate, Cranioplasty, Preformed, Non-Alterable
- Decision date
- 2023-11-09
- Date received
- 2023-06-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K231920.pdf
Official FDA record: K231920
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.