SternalPlate Expansion— 510(k) K243491
Substantially EquivalentStryker Leibinger GmbH & Co KG
FDA 510(k) clearance K243491 for SternalPlate Expansion, Substantially Equivalent on 2024-12-11. Applicant: Stryker Leibinger GmbH & Co KG.
Clearance details
- Applicant
- Stryker Leibinger GmbH & Co KG
- Product code
- Code HRS
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Freiburg, DE
Adverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
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.