ORTHOPEDIC ALLIANCE SPINE SYSTEM— 510(k) K033826

Substantially Equivalent

Orthopedic Alliance, LLC

FDA 510(k) clearance K033826 for ORTHOPEDIC ALLIANCE SPINE SYSTEM, Substantially Equivalent on 2004-07-01. Applicant: Orthopedic Alliance, LLC.

Clearance details

Applicant: Orthopedic Alliance, LLC
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2003-12-10
Decision date: 2004-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murrieta, 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.