ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS— 510(k) K030958

Substantially Equivalent

Ortho Tec, LLC

FDA 510(k) clearance K030958 for ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS, Substantially Equivalent on 2003-11-20. Applicant: Ortho Tec, LLC.

Clearance details

Applicant: Ortho Tec, LLC
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2003-03-27
Decision date: 2003-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: California, CA, US

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Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

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.