Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System— 510(k) K261353

Name: FDA 510(k) clearance K261353
Creator: U.S. Food and Drug Administration
Published: 2026-07-15

Substantially Equivalent

Kyocera 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.

Clearance details

Applicant: Kyocera Medical Technologies, Inc.
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2026-04-24
Decision date: 2026-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redlands, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVD

view all

K261408 — SABER-XA System2026-08-03
K261809 — Interwedge® Standalone Lateral2026-07-31
K260810 — Anteralign LS coverplate2026-06-10
K254202 — MectaLIF 3D Metal Anterior2026-05-05
K253401 — SCRIPT Implant System2026-04-29

More clearances from Kyocera Medical Technologies, Inc.

view all

K242045 — Initia T3 Acetabular Hemispherical Shell System2025-04-10
K242928 — Tesera-k SC System2025-04-10
K242771 — Tesera-k PL System and Tesera-k XL System2025-03-20
K243295 — Initia Knee System2025-01-13
K243015 — Skyway Anterior Cervical Plate System2024-11-05

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.