IMPLANT, H.P. CONDYLAR
Device Facts
| Record ID | K781870 |
|---|---|
| Device Name | IMPLANT, H.P. CONDYLAR |
| Applicant | Dow Corning Corp. Healthcare Industries Materials |
| Product Code | KWD · Orthopedic |
| Decision Date | Feb 9, 1979 |
| 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.