K230211
- 510(k) number
- K230211
- Device name
- CranioXpand
- Applicant
- KLS-Martin L.P. FL · US
- Product code
- PBJ — Cranial Distraction System
- Decision date
- 2023-11-21
- Date received
- 2023-01-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K230211.pdf
Official FDA record: K230211
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.