MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS— 510(k) K001548
Substantially EquivalentHowmedica Osteonics Corp.
FDA 510(k) clearance K001548 for MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS, Substantially Equivalent on 2000-06-07. Applicant: Howmedica Osteonics Corp..
Clearance details
- Applicant
- Howmedica Osteonics Corp.
- Product code
- Code KRO
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rutherford, NJ, US
Adverse events under product code KRO
product code KRO- Death
- 19
- Injury
- 4,841
- Total
- 4,860
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.