Rubicon Lumbar Interbody Fusion System— 510(k) K181030

Substantially Equivalent

Rubicon Spine, LLC

FDA 510(k) clearance K181030 for Rubicon Lumbar Interbody Fusion System, Substantially Equivalent on 2018-07-17. Applicant: Rubicon Spine, LLC.

Clearance details

Applicant: Rubicon Spine, LLC
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2018-04-18
Decision date: 2018-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sarasota, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.