K261353
- 510(k) number
- K261353
- Device name
- Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System
- Applicant
- Kyocera Medical Technologies, Inc. CA · US
- Product code
- OVD — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2026-07-15
- Date received
- 2026-04-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K261353.pdf
Official FDA record: K261353
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.