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
ITQClass I

Joint, Knee, External Brace

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

ITQ is the FDA product code for Joint, Knee, External Brace, a class I device type, regulated under 21 CFR 890.3475. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and 12 recalls.

Classification record

Product code
ITQ
Device name
Joint, Knee, 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
15
Ingested recalls
12

Clearances, product code ITQ

By decision year
15 clearances under product code ITQ with a decision year between 1977 and 1983, 1977 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code ITQ by decision year
YearClearances
19774
19781
19801
19814
19823
19832

Applicants with the most clearances

Product code ITQ
Applicants holding the most 510(k) clearances under product code ITQ
ApplicantClearances
Med Fusion Systems, Inc.4
Mizuho Orthopedic Systems Inc2
Surgical Appliance Industries, Inc.2
Warm & Form, Orthopedic Materials2
Aircast, Inc.1
Hosmer Dorrance Corp.1
Innovation Sports, Inc.1
Medical Design & Manufacturing Corp.1
Omni Scientific, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 443 companies shown, in name order