DeviceClearance

K181603

Substantially Equivalent

EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System

Applicant
K2m, Inc.
Product code
NKG
Advisory panel
Orthopedic
Date received
Decision date
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, through . 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.