MUTARS® femoral stem cemented 160 mm and 200 mm— 510(k) K240391
Substantially EquivalentImplantcast GmbH
FDA 510(k) clearance K240391 for MUTARS® femoral stem cemented 160 mm and 200 mm, Substantially Equivalent on 2024-10-24. Applicant: Implantcast GmbH.
Clearance details
- Applicant
- Implantcast GmbH
- Product code
- Code LZO
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buxtehude, DE
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.