RANGE/DENALI/MESA Spinal System— 510(k) K153031

Substantially Equivalent

K2m, Incorporated

FDA 510(k) clearance K153031 for RANGE/DENALI/MESA Spinal System, Substantially Equivalent on 2015-11-17. Applicant: K2m, Incorporated.

Clearance details

Applicant: K2m, Incorporated
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2015-10-19
Decision date: 2015-11-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Leesburg, VA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.