SWANSON TITANIUM CARPAL SCAPHOID IMPLANT
Device Facts
| Record ID | K864490 |
|---|---|
| Device Name | SWANSON TITANIUM CARPAL SCAPHOID IMPLANT |
| Applicant | Dow Corning Wright |
| Product Code | KWO · Orthopedic |
| Decision Date | Apr 15, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3760 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A wrist joint carpal scaphoid polymer prosthesis is a one-piece device made of silicone elastomer intended to be implanted to replace the carpal scaphoid bone of the wrist.