K250486
- 510(k) number
- K250486
- Device name
- Skyway Anterior Cervical Plate System
- Applicant
- Kyocera Medical Technologies Inc. (KMTI) CA · US
- Product code
- KWQ — Appliance, Fixation, Spinal Intervertebral Body
- Decision date
- 2025-04-10
- Date received
- 2025-02-19
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250486.pdf
Official FDA record: K250486
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.