Arco-SA Lumbar Cage System— 510(k) K182195

Name: FDA 510(k) clearance K182195
Creator: U.S. Food and Drug Administration
Published: 2018-11-09

Substantially Equivalent

Neurostructures, Inc.

FDA 510(k) clearance K182195 for Arco-SA Lumbar Cage System, Substantially Equivalent on 2018-11-09. Applicant: Neurostructures, Inc.. Device class: 2.

Clearance details

Applicant: Neurostructures, Inc.
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2018-08-14
Decision date: 2018-11-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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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.