Trident II Acetabular System— 510(k) K191358
Substantially EquivalentHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
FDA 510(k) clearance K191358 for Trident II Acetabular System, Substantially Equivalent on 2019-10-24. Applicant: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics.
Clearance details
- Applicant
- Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
- Product code
- Code LPH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mahwah, NJ, US
Adverse events under product code LPH
product code LPH- Death
- 73
- Injury
- 31,640
- Malfunction
- 3,358
- Other
- 2
- Total
- 35,073
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.