Splint, Abduction, Congenital Hip Dislocation
An Abduction Splint for Congenital Hip Dislocation is an orthotic device used in Physical Medicine and pediatric orthopedics to maintain the hip in a position of abduction and flexion in infants with developmental dysplasia of the hip or congenital hip dislocation, promoting normal acetabular development and hip joint reduction. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is IOZ, regulated under 21 CFR 890.3665, within the Physical Medicine medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.
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Basic Information
- Product Code
- IOZ
- Device Class
- FDA class 1
- Regulation Number
- 890.3665
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K830243 | ABDUCTION PILLOW | Mar 08, 1983 | Substantially Equivalent | Warm & Form, Orthopedic Materials |
| K823820 | ABDUCTION PILLOW | Jan 14, 1983 | Substantially Equivalent | Danek Medical, Inc. |
| K810557 | HIP ABDUCTION SPLINT | Mar 13, 1981 | Substantially Equivalent | Orthomedics |
| K780375 | PAVLIK HARNESS | Mar 15, 1978 | Substantially Equivalent | Biomet, Inc. |
FEI Numbers
This FDA classification entry is associated with 34 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 34 registration numbers. Click on an entry to view related FDA registrations.