K201701
Substantially EquivalentR3 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
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.