Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System— 510(k) K223719

Substantially Equivalent

Aegis Spine, Inc.

FDA 510(k) clearance K223719 for Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System, Substantially Equivalent on 2023-01-11. Applicant: Aegis Spine, Inc..

Clearance details

Applicant: Aegis Spine, Inc.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2022-12-12
Decision date: 2023-01-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Englewood, CO, 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.