510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
ITWClass I

Joint, Ankle, External Brace

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

ITW is the FDA product code for Joint, Ankle, 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 3 recalls.

Classification record

Product code
ITW
Device name
Joint, Ankle, 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
3

Clearances, product code ITW

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

Applicants with the most clearances

Product code ITW
Applicants holding the most 510(k) clearances under product code ITW
ApplicantClearances
Fred Sammons, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 447 companies shown, in name order