Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System— 510(k) K213328
Substantially EquivalentStryker GmbH
FDA 510(k) clearance K213328 for Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System, Substantially Equivalent on 2022-02-11. Applicant: Stryker GmbH.
Clearance details
- Applicant
- Stryker GmbH
- Product code
- Code HSB
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
Adverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
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.