BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT
Device Facts
| Record ID | K894604 |
|---|---|
| Device Name | BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT |
| Applicant | Biopro, Inc. |
| Product Code | KXA · Orthopedic |
| Decision Date | Nov 17, 1989 |
| Decision | SN |
| 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.
