BIPOLAR HIP SYSTEM
Device Facts
| Record ID | K892398 |
|---|---|
| Device Name | BIPOLAR HIP SYSTEM |
| Applicant | Orthomet, Inc. |
| Product Code | KXA · Orthopedic |
| Decision Date | May 23, 1989 |
| 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.
