DeviceClearance

K003504

Substantially Equivalent

RT-PLUS MODULAR CEMENTED KNEE COMPONENTS

Applicant
Plus Orthopedics
Product code
KRO
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KRO

product code KRO
Death
19
Injury
4,841
Total
4,860

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.