K243715
- 510(k) number
- K243715
- Device name
- Synthes Patient Specific Implants
- Applicant
- Synthes GmbH CH
- Product code
- GXN — Plate, Cranioplasty, Preformed, Non-Alterable
- Decision date
- 2025-11-12
- Date received
- 2024-12-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K243715.pdf
Official FDA record: K243715
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.