K242771
- 510(k) number
- K242771
- Device name
- Tesera-k PL System and Tesera-k XL System
- Applicant
- Kyocera Medical Technologies, Inc. CA · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2025-03-20
- Date received
- 2024-09-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K242771.pdf
Official FDA record: K242771
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.