IMPLANT, HINGE TOE, FLEX.
Device Facts
| Record ID | K780132 |
|---|---|
| Device Name | IMPLANT, HINGE TOE, FLEX. |
| Applicant | Dow Corning Corp. Healthcare Industries Materials |
| Product Code | KWH · Orthopedic |
| Decision Date | Feb 6, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3720 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.
