SILASTIC H.P. TRAPEXIAL IMPLANT
Device Facts
| Record ID | K781756 |
|---|---|
| Device Name | SILASTIC H.P. TRAPEXIAL IMPLANT |
| Applicant | Dow Corning Corp. Healthcare Industries Materials |
| Product Code | KYI · Orthopedic |
| Decision Date | Nov 15, 1978 |
| 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.
