LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT
Device Facts
| Record ID | K883212 |
|---|---|
| Device Name | LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT |
| Applicant | Implant Technology, Inc. |
| Product Code | KXA · Orthopedic |
| Decision Date | Nov 22, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A hip joint femoral (hemi-hip) metallic resurfacing prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral resurfacing component made of alloys, such as cobalt-chromium-molybdenum.
