DSS STABILIZATION SYSTEM-RIGID— 510(k) K120491

Unknown

Paradigm Spine, LLC

FDA 510(k) clearance K120491 for DSS STABILIZATION SYSTEM-RIGID, Unknown on 2012-05-09. Applicant: Paradigm Spine, LLC.

Clearance details

Applicant: Paradigm Spine, LLC
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 2012-02-17
Decision date: 2012-05-09
Decision: Unknown
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.