K253854
- 510(k) number
- K253854
- Device name
- MONTAGE XT Cranial Cement
- Applicant
- Orthocon, Inc. CT · US
- Product code
- GXP — Methyl Methacrylate For Cranioplasty
- Decision date
- 2026-01-02
- Date received
- 2025-12-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K253854.pdf
Official FDA record: K253854
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.