Irix-C Cervical Integrated Fusion System— 510(k) K162944

Substantially Equivalent

X-Spine Systems, Inc.

FDA 510(k) clearance K162944 for Irix-C Cervical Integrated Fusion System, Substantially Equivalent on 2016-11-07. Applicant: X-Spine Systems, Inc..

Clearance details

Applicant: X-Spine Systems, Inc.
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2016-10-21
Decision date: 2016-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miamisburg, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.