Tesera-k SC System— 510(k) K242928

Name: FDA 510(k) clearance K242928
Creator: U.S. Food and Drug Administration
Published: 2025-04-10

Substantially Equivalent

Kyocera Medical Technologies, Inc.

FDA 510(k) clearance K242928 for Tesera-k SC System, Substantially Equivalent on 2025-04-10. Applicant: Kyocera Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Kyocera Medical Technologies, Inc.
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2024-09-24
Decision date: 2025-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redlands, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVE

view all

K261882 — Pisces-SC Standalone Cervical Interbody System2026-08-21
K261451 — ZSAlign Cervical Interbody System2026-07-31
K262094 — E3D-C Interbody System2026-07-22
K261279 — DeltaNEC Interbody System2026-06-22
K252982 — CONDUIT ZERO-P VA Secured Spacer System2026-06-18

More clearances from Kyocera Medical Technologies, Inc.

view all

K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System2026-07-15
K242045 — Initia T3 Acetabular Hemispherical Shell 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 OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.