LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT— 510(k) K883212
Substantially EquivalentImplant Technology, Inc.
FDA 510(k) clearance K883212 for LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT, Substantially Equivalent on 1988-11-22. Applicant: Implant Technology, Inc..
Clearance details
- Applicant
- Implant Technology, Inc.
- Product code
- Code KXA
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Secaucus, NJ, US
Adverse events under product code KXA
product code KXA- Injury
- 324
- Total
- 324
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.