IOZ — Splint, Abduction, Congenital Hip Dislocation Class I

FDA Device Classification

FDA product code IOZ covers "Splint, Abduction, Congenital Hip Dislocation", a Class I medical device regulated under 21 CFR 890.3665. Submissions are reviewed by the Physical Medicine panel. At least 4 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
IOZ
Device Class
Class I
Regulation Number
890.3665
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K830243warm and form, orthopedic materialsABDUCTION PILLOWMarch 8, 1983
K823820danek medicalABDUCTION PILLOWJanuary 14, 1983
K810557orthomedicsHIP ABDUCTION SPLINTMarch 13, 1981
K780375biometPAVLIK HARNESSMarch 15, 1978