ARTIFLEX(TM)
Device Facts
| Record ID | K910274 |
|---|---|
| Device Name | ARTIFLEX(TM) |
| Applicant | Beiersdorf, Inc. |
| Product Code | LGF · Orthopedic |
| Decision Date | Mar 5, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.5940 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A cast component is a device intended for medical purposes to protect or support a cast. This generic type of device includes the cast heel, toe cap, cast support, and walking iron.
