NEW JERSEY FEMORAL RESURFACING COMPONENT
Device Facts
| Record ID | K842233 |
|---|---|
| Device Name | NEW JERSEY FEMORAL RESURFACING COMPONENT |
| Applicant | Endomedics, Inc. |
| Product Code | KXA · Orthopedic |
| Decision Date | Jul 20, 1984 |
| 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.
