IOZ · Splint, Abduction, Congenital Hip Dislocation
Physical Medicine · 21 CFR 890.3665 · Class 1
Overview
| Product Code | IOZ |
|---|---|
| Device Name | Splint, Abduction, Congenital Hip Dislocation |
| Regulation | 21 CFR 890.3665 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
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).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K830243 | ABDUCTION PILLOW | Warm & Form, Orthopedic Materials | Mar 8, 1983 | SESE |
| K823820 | ABDUCTION PILLOW | Danek Medical, Inc. | Jan 14, 1983 | SESE |
| K810557 | HIP ABDUCTION SPLINT | Orthomedics | Mar 13, 1981 | SESE |
| K780375 | PAVLIK HARNESS | Biomet, Inc. | Mar 15, 1978 | SESE |
Top Applicants
- Biomet, Inc. — 1 clearance
- Danek Medical, Inc. — 1 clearance
- Orthomedics — 1 clearance
- Warm & Form, Orthopedic Materials — 1 clearance
