SWANSON TITANIUM GREAT TOE IMPLANT
Device Facts
| Record ID | K864492 |
|---|---|
| Device Name | SWANSON TITANIUM GREAT TOE IMPLANT |
| Applicant | Dow Corning Wright |
| Product Code | KWD · Orthopedic |
| Decision Date | Apr 15, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3730 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.