K231475
- 510(k) number
- K231475
- Device name
- MONTAGE-QS Settable, Resorbable Bone Putty
- Applicant
- Orthocon, Inc. CT · US
- Product code
- GXP — Methyl Methacrylate For Cranioplasty
- Decision date
- 2023-10-12
- Date received
- 2023-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K231475.pdf
Official FDA record: K231475
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.