Tesera-k SC System— 510(k) K242928

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..

Clearance details

Applicant: Kyocera Medical Technologies, Inc.
Product code: Code OVE
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 ↗

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.