K253447
- 510(k) number
- K253447
- Device name
- Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
- Applicant
- Orthocon, Inc. CT · US
- Product code
- GXR — Cover, Burr Hole
- Decision date
- 2026-03-16
- Date received
- 2025-10-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K253447.pdf
Official FDA record: K253447
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.