SWANSON TITANIUM CONDYLAR IMPLANT
Device Facts
| Record ID | K864488 |
|---|---|
| Device Name | SWANSON TITANIUM CONDYLAR IMPLANT |
| Applicant | Dow Corning Wright |
| Product Code | KYI · Orthopedic |
| Decision Date | Apr 15, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3770 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.
