DeviceClearance

K233735

Substantially Equivalent

ADIRA™ Lateral Plate System

Applicant
Globus Medical, Inc.
Product code
KWQ
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Audubon, PA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ
Death
8
Injury
1,212
Malfunction
1,233
Total
2,453

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.