Tesera-k ALIF System— 510(k) K212980

Substantially Equivalent

Kyocera Medical Technologies, Inc.

FDA 510(k) clearance K212980 for Tesera-k ALIF System, Substantially Equivalent on 2022-01-07. Applicant: Kyocera Medical Technologies, Inc..

Clearance details

Applicant: Kyocera Medical Technologies, Inc.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2021-09-17
Decision date: 2022-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redlands, CA, US

Download summary PDF View on FDA.gov ↗

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.