KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System— 510(k) K193320

Name: FDA 510(k) clearance K193320
Creator: U.S. Food and Drug Administration
Published: 2020-02-04

Substantially Equivalent

Kyocera Medical Technologies, Inc.

FDA 510(k) clearance K193320 for KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System, Substantially Equivalent on 2020-02-04. 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: 2019-12-02
Decision date: 2020-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redlands, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVD

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K262025 — Innovasis AxTiHA® Stand-Alone ALIF System +2 more2026-09-11
K261408 — SABER-XA System2026-08-03
K261809 — Interwedge® Standalone Lateral2026-07-31
K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System2026-07-15
K260810 — Anteralign LS coverplate2026-06-10

More clearances from Kyocera Medical Technologies, Inc.

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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.