ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System— 510(k) K221050

Substantially Equivalent

Aegis Spine, Inc.

FDA 510(k) clearance K221050 for ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System, Substantially Equivalent on 2022-06-30. Applicant: Aegis Spine, Inc..

Clearance details

Applicant: Aegis Spine, Inc.
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2022-04-11
Decision date: 2022-06-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

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.