K250334
- 510(k) number
- K250334
- Device name
- Fusion Craniofacial Implant; Fusion Skull Implant
- Applicant
- Kelyniam Global, Inc. CT · US
- Product code
- GWO — Plate, Cranioplasty, Preformed, Alterable
- Decision date
- 2025-07-25
- Date received
- 2025-02-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250334.pdf
Official FDA record: K250334
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.