K242928
- 510(k) number
- K242928
- Device name
- Tesera-k SC System
- Applicant
- Kyocera Medical Technologies, Inc. CA · US
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2025-04-10
- Date received
- 2024-09-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.1 MB · U.S. public domain
Also available from FDA: K242928.pdf
Official FDA record: K242928
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.