METALLIC RADIAL HEAD IMPLANTS
Device Facts
| Record ID | K944507 |
|---|---|
| Device Name | METALLIC RADIAL HEAD IMPLANTS |
| Applicant | Wrightmedicaltechnologyinc |
| Product Code | KWI · Orthopedic |
| Decision Date | Jul 13, 1995 |
| Decision | SN |
| 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.
