K210874

Substantially Equivalent

Reliance Spinal Screw System

Applicant
Reliance Medical Systems, LLC
Product code
NKB
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Bountiful, UT, US
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.