K223719

Substantially Equivalent

Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System

Applicant: Aegis Spine, Inc.
Product 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

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.