K231766
- 510(k) number
- K231766
- 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
- 2023-09-12
- Date received
- 2023-06-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K231766.pdf
Official FDA record: K231766
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.