EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System— 510(k) K181603

Substantially Equivalent

K2m, Inc.

FDA 510(k) clearance K181603 for EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System, Substantially Equivalent on 2018-10-05. Applicant: K2m, Inc..

Clearance details

Applicant: K2m, Inc.
Product code: Code NKG
Advisory panel: Orthopedic
Date received: 2018-06-19
Decision date: 2018-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leesburg, VA, US

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Adverse events under product code NKG

product code NKG

Death: 15
Injury: 1,090
Malfunction: 529
Total: 1,634

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.