LINK ACETABULAR MESH— 510(k) K844225
Substantially EquivalentWaldemar Link GmbH & Co. KG
FDA 510(k) clearance K844225 for LINK ACETABULAR MESH, Substantially Equivalent on 1984-11-14. Applicant: Waldemar Link GmbH & Co. KG.
Clearance details
- Applicant
- Waldemar Link GmbH & Co. KG
- Product code
- Code FTM
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- E. Hanover, NJ, US
Adverse events under product code FTM
product code FTM- Death
- 17
- Injury
- 2,174
- Total
- 2,191
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.