K261265
- 510(k) number
- K261265
- Device name
- Permatage XT Settable Bone Putty
- Applicant
- Orthocon, Inc. CT · US
- Product code
- GXP — Methyl Methacrylate For Cranioplasty
- Decision date
- 2026-06-15
- Date received
- 2026-04-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K261265.pdf
Official FDA record: K261265
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.