K241027
- 510(k) number
- K241027
- Device name
- Permatage Settable Bone Putty
- Applicant
- Orthocon, Inc. CT · US
- Product code
- GXP — Methyl Methacrylate For Cranioplasty
- Decision date
- 2024-09-26
- Date received
- 2024-04-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K241027.pdf
Official FDA record: K241027
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.