K201701

Substantially Equivalent

R3 HA Coated Acetabular Shells

Applicant
Smith & Nephew, Inc.
Product code
MBL
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cordova, TN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MBL

product code MBL
Injury
439
Total
439

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.