KTDClass I

Orthosis, Abdominal

21 CFR 890.3490 / Physical Medicine

KTD is the FDA product code for Orthosis, Abdominal, a class I device type, regulated under 21 CFR 890.3490. As of 2026-09-10, FDA records hold 3 510(k) clearances under this code, the most recent dated 1982-12-30, and no recalls.

Classification record

Product code: KTD
Device name: Orthosis, Abdominal
Regulation: 21 CFR 890.3490
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 KTD

By decision year

3 clearances under product code KTD with a decision year between 1978 and 1982, 1982 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code KTD by decision year
Year	Clearances
1978	1
1982	2

Applicants with the most clearances

Product code KTD

Applicants holding the most 510(k) clearances under product code KTD
Applicant	Clearances
Warm & Form, Orthopedic Materials	2
Zimmer GmbH	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 89 companies shown, in name order

Recent clearances

Product code KTD

Recent recalls

Product code KTD

FDA records show no recalls under product code KTD.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)