Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System— 510(k) K261353
Substantially EquivalentKyocera Medical Technologies, Inc.
FDA 510(k) clearance K261353 for Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System, Substantially Equivalent on 2026-07-15. Applicant: Kyocera Medical Technologies, Inc.. Device class: 2.
Summary
Kyocera Medical Technologies' clearance covers the Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System, the Tesera-K XL System, and the Lumbar Anchor System. They're filed under OVD, lumbar intervertebral fusion devices with integrated fixation.
Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
Kyocera filed from Redlands, California. The decision came 82 calendar days after receipt (April 24 to July 15, 2026).
Clearance details
- Applicant
- Kyocera Medical Technologies, Inc.
- Product code
- Product code OVD
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redlands, CA, US
Recent devices under product code OVD
view allMore clearances from Kyocera Medical Technologies, Inc.
view allAdverse events under product code OVD
product code OVD- Death
- 5
- Injury
- 495
- Total
- 500
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.