PAVLIK HARNESS
Device Facts
| Record ID | K780375 |
|---|---|
| Device Name | PAVLIK HARNESS |
| Applicant | Biomet, Inc. |
| Product Code | IOZ · Physical Medicine |
| Decision Date | Mar 15, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3665 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A congenital hip dislocation abduction splint is a device intended for medical purposes to stabilize the hips of a young child with dislocated hips in an abducted position (away from the midline).