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

Joint, Hip, External Brace

21 CFR 890.3475 / Physical Medicine
FDA source (opens on fda.gov)

ITS is the FDA product code for Joint, Hip, External Brace, a class I device type, regulated under 21 CFR 890.3475. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
ITS
Device name
Joint, Hip, External Brace
Regulation
21 CFR 890.3475
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
1
Ingested recalls
0

Clearances, product code ITS

By decision year
1 clearance under product code ITS with a decision year between 1978 and 1978, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ITS by decision year
YearClearances
19781

Applicants with the most clearances

Product code ITS
Applicants holding the most 510(k) clearances under product code ITS
ApplicantClearances
Hosmer Dorrance Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 110 companies shown, in name order