SUTTER PHALANGEAL CAP
Device Facts
| Record ID | K875249 |
|---|---|
| Device Name | SUTTER PHALANGEAL CAP |
| Applicant | Sutter Biomedical, Inc. |
| Product Code | KWD · Orthopedic |
| Decision Date | Feb 3, 1988 |
| 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.