Stable-C Interbody System— 510(k) K181621

Substantially Equivalent

Nexus Spine, LLC

FDA 510(k) clearance K181621 for Stable-C Interbody System, Substantially Equivalent on 2018-10-19. Applicant: Nexus Spine, LLC.

Clearance details

Applicant: Nexus Spine, LLC
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2018-06-20
Decision date: 2018-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, 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.