KWO · Prosthesis, Wrist, Carpal Scaphoid
Orthopedic · 21 CFR 888.3760 · Class 2
Overview
| Product Code | KWO |
|---|---|
| Device Name | Prosthesis, Wrist, Carpal Scaphoid |
| Regulation | 21 CFR 888.3760 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A wrist joint carpal scaphoid polymer prosthesis is a one-piece device made of silicone elastomer intended to be implanted to replace the carpal scaphoid bone of the wrist.
Classification Rationale
Class II.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K864490 | SWANSON TITANIUM CARPAL SCAPHOID IMPLANT | Dow Corning Wright | Apr 15, 1987 | SESE |
Top Applicants
- Dow Corning Wright — 1 clearance
