DeviceClearance

Product code KTT— Orthopedic

EBI XFIX DFS SYSTEM

Classification name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device class
Class 2
Regulation
21 CFR 888.3030
Advisory panel
Orthopedic
Total cleared
404
First cleared
Most recent

Market context for product code KTT

FDA has cleared 404 devices under product code KTT between 1979 and 2026, filed by 154 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code KTT

Adverse events under product code KTT

product code KTT
Death
11
Injury
3,097
Malfunction
1,261
Total
4,369

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code KTT

1–100 of 404

Data sourced from openFDA. This site is unofficial and independent of the FDA.