IOZ · Class I · 21 CFR 890.3665

FDA Product Code IOZ: Splint, Abduction, Congenital Hip Dislocation

Leading manufacturers include Biomet, Inc., Danek Medical, Inc. and Warm & Form, Orthopedic Materials.

4

Total

4

Cleared

22d

Avg days

1978

Since

FDA 510(k) Cleared Splint, Abduction, Congenital Hip Dislocation Devices (Product Code IOZ)

4 devices

1–4 of 4

Cleared Mar 08, 1983

ABDUCTION PILLOW

Warm & Form, Orthopedic Materials

Physical Medicine · 42d

Cleared Jan 14, 1983

ABDUCTION PILLOW

Danek Medical, Inc.

Physical Medicine · 28d

Cleared Mar 15, 1978

Physical Medicine · 7d

About Product Code IOZ - Regulatory Context

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,730 total devices indexed.

Latest clearance: Mar 08, 1983

Product Code Info

Code	IOZ
Device class	Class I
CFR	21 CFR 890.3665
Panel	Physical Medicine

Verify on FDA.gov

View IOZ classification on FDA.gov →