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

Splint, Denis Brown

21 CFR 890.3675 / Physical Medicine
FDA source (opens on fda.gov)

ITN is the FDA product code for Splint, Denis Brown, a class I device type, regulated under 21 CFR 890.3675. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ITN
Device name
Splint, Denis Brown
Regulation
21 CFR 890.3675
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
3
Ingested recalls
0

Clearances, product code ITN

By decision year
3 clearances under product code ITN with a decision year between 1982 and 2007, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ITN by decision year
YearClearances
19821
20031
20071

Applicants with the most clearances

Product code ITN
Applicants holding the most 510(k) clearances under product code ITN
ApplicantClearances
Abbott Medical1
The Langer Group1
Yeou Eir Shuen Machinery Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order