Comprehensive SRS/Nexel Elbow— 510(k) K153398
Substantially EquivalentBiomet Manufacturing Corp
FDA 510(k) clearance K153398 for Comprehensive SRS/Nexel Elbow, Substantially Equivalent on 2016-02-03. Applicant: Biomet Manufacturing Corp.
Clearance details
- Applicant
- Biomet Manufacturing Corp
- Product code
- Code JDC
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Adverse events under product code JDC
product code JDC- Injury
- 1,050
- Total
- 1,050
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.