ERS RADIAL HEAD REPLACEMENT
Device Facts
| Record ID | K000658 |
|---|---|
| Device Name | ERS RADIAL HEAD REPLACEMENT |
| Applicant | DePuy Orthopaedics, Inc. |
| Product Code | KWI · Orthopedic |
| Decision Date | May 11, 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.
