MESA SPINAL SYSTEM— 510(k) K052398

Substantially Equivalent

K2m, LLC

FDA 510(k) clearance K052398 for MESA SPINAL SYSTEM, Substantially Equivalent on 2005-12-07. Applicant: K2m, LLC.

Clearance details

Applicant: K2m, LLC
Product code: Code MNI
Advisory panel: Orthopedic
Date received: 2005-08-31
Decision date: 2005-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leesburg, VA, 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.