Caspian OCT/MESA Mini/DENALI Mini Spinal System— 510(k) K153370

Substantially Equivalent

K2m, Incorporated

FDA 510(k) clearance K153370 for Caspian OCT/MESA Mini/DENALI Mini Spinal System, Substantially Equivalent on 2016-02-16. Applicant: K2m, Incorporated.

Clearance details

Applicant: K2m, Incorporated
Product code: Code NKG
Advisory panel: Orthopedic
Date received: 2015-11-23
Decision date: 2016-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leesburg, VA, US

Download summary PDF View on FDA.gov ↗

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.