STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT— 510(k) K111065
Substantially EquivalentHowmedica Osteonics Corp. Dba Stryker Orthopeadics
FDA 510(k) clearance K111065 for STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT, Substantially Equivalent on 2011-07-14. Applicant: Howmedica Osteonics Corp. Dba Stryker Orthopeadics.
Clearance details
- Applicant
- Howmedica Osteonics Corp. Dba Stryker Orthopeadics
- Product code
- Code GWO
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
Adverse events under product code GWO
product code GWO- Malfunction
- 583
- Total
- 583
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.