SWANSON TITANIUM CARPAL LUNATE IMPLANT
Device Facts
| Record ID | K864491 |
|---|---|
| Device Name | SWANSON TITANIUM CARPAL LUNATE IMPLANT |
| Applicant | Dow Corning Wright |
| Product Code | KWN · Orthopedic |
| Decision Date | Apr 15, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3750 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A wrist joint carpal lunate prosthesis is a one-piece device made of silicone elastomer intended to be implanted to replace the carpal lunate bone of the wrist.