Versacem Acetabular Shell and Double Mobility HC Liners— 510(k) K241767
Substantially EquivalentMedacta International S.A.
FDA 510(k) clearance K241767 for Versacem Acetabular Shell and Double Mobility HC Liners, Substantially Equivalent on 2025-03-06. Applicant: Medacta International S.A..
Clearance details
- Applicant
- Medacta International S.A.
- Product code
- Code LZO
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Castel San Pietro, CH
Adverse events under product code LZO
product code LZO- Death
- 17
- Injury
- 12,942
- Malfunction
- 1,756
- Total
- 14,715
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.