Tornier Humeral Reconstruction System (Tornier HRS)— 510(k) K241609
Substantially EquivalentStryker Corporation (Tornier, Inc.)
FDA 510(k) clearance K241609 for Tornier Humeral Reconstruction System (Tornier HRS), Substantially Equivalent on 2024-09-10. Applicant: Stryker Corporation (Tornier, Inc.).
Clearance details
- Applicant
- Stryker Corporation (Tornier, Inc.)
- Product code
- Code KWS
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bloomington, MN, US
Adverse events under product code KWS
product code KWS- Death
- 6
- Injury
- 9,652
- Malfunction
- 1,385
- Other
- 1
- Total
- 11,044
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.