RANGE SPINAL SYSTEM (MESA AND DENALI)— 510(k) K112920

Name: FDA 510(k) clearance K112920
Creator: U.S. Food and Drug Administration
Published: 2011-12-21

Substantially Equivalent

K2m, Inc.

FDA 510(k) clearance K112920 for RANGE SPINAL SYSTEM (MESA AND DENALI), Substantially Equivalent on 2011-12-21. Applicant: K2m, Inc.. Device class: 2.

Clearance details

Applicant: K2m, Inc.
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2011-10-03
Decision date: 2011-12-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Leesburg, VA, US

Download summary PDF View on FDA.gov ↗

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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.