510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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IOZClass I

Splint, Abduction, Congenital Hip Dislocation

21 CFR 890.3665 / Physical Medicine
FDA source (opens on fda.gov)

IOZ is the FDA product code for Splint, Abduction, Congenital Hip Dislocation, a class I device type, regulated under 21 CFR 890.3665. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IOZ
Device name
Splint, Abduction, Congenital Hip Dislocation
Regulation
21 CFR 890.3665
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code IOZ

By decision year
4 clearances under product code IOZ with a decision year between 1978 and 1983, 1983 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code IOZ by decision year
YearClearances
19781
19811
19832

Applicants with the most clearances

Product code IOZ
Applicants holding the most 510(k) clearances under product code IOZ
ApplicantClearances
Zimmer GmbH1
Danek Medical, Inc.1
Orthomedics1
Warm & Form, Orthopedic Materials1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order