DeviceClearance

K091956

Substantially Equivalent

HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712

Applicant
Encore Medical L.P.
Product code
OIY
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Austin, TX, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OIY

product code OIY
Injury
607
Total
607

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.