MODIFICATION TO LANX SPINAL FIXATION SYSTEM— 510(k) K093285

Substantially Equivalent

Lanx, LLC

FDA 510(k) clearance K093285 for MODIFICATION TO LANX SPINAL FIXATION SYSTEM, Substantially Equivalent on 2009-12-10. Applicant: Lanx, LLC.

Clearance details

Applicant: Lanx, LLC
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2009-10-20
Decision date: 2009-12-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Broomfield, CO, 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.