RADIAL HEAD IMPLANT
Device Facts
| Record ID | K002644 |
|---|---|
| Device Name | RADIAL HEAD IMPLANT |
| Applicant | Avanta Orthopaedics, Inc. |
| Product Code | KWI · Orthopedic |
| Decision Date | Nov 20, 2000 |
| 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.
