DeviceClearance

K213849

Substantially Equivalent

SafeOp 2: Neural Informatix System

Applicant
Alphatec Spine, Inc.
Product code
GWF
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carlsbad, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GWF

product code GWF
Malfunction
2,364
Other
4
Total
2,368

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.