Oculus-SA Lumbar Cage System— 510(k) K202190

Substantially Equivalent

Neurostructures

FDA 510(k) clearance K202190 for Oculus-SA Lumbar Cage System, Substantially Equivalent on 2020-10-02. Applicant: Neurostructures.

Clearance details

Applicant: Neurostructures
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2020-08-05
Decision date: 2020-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.