CONTOUR HA COATED RECONSTRUCTION RING— 510(k) K040680
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K040680 for CONTOUR HA COATED RECONSTRUCTION RING, Substantially Equivalent on 2004-06-14. Applicant: Smith & Nephew, Inc..
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Code MEH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cordova, TN, US
Adverse events under product code MEH
product code MEH- Injury
- 2,021
- Total
- 2,021
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.