CL UNIVERSAL HIP DEVICE
Device Facts
| Record ID | K885146 |
|---|---|
| Device Name | CL UNIVERSAL HIP DEVICE |
| Applicant | Lima Intl. Corp. |
| Product Code | KWI · Orthopedic |
| Decision Date | Apr 24, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3170 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.
