ANTERIS Thoracolumbar Plate System— 510(k) K260015

Substantially Equivalent

SpineCraft

FDA 510(k) clearance K260015 for ANTERIS Thoracolumbar Plate System, Substantially Equivalent on 2026-03-04. Applicant: SpineCraft.

Clearance details

Applicant: SpineCraft
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2026-01-05
Decision date: 2026-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westmont, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.