DeviceClearance

K171582

Substantially Equivalent

NEO Pedicle Screw System™

Applicant
Neo Medical SA
Product code
NKB
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Villette (Lavaux), CH
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, 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.