Product code KFX— Physical Medicine

ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.

Classification name
Assembly, Thigh/Knee/Shank/Ankle/Foot, External
Device class
Class 2
Regulation
21 CFR 890.3500
Advisory panel
Physical Medicine
Total cleared
4
First cleared
Most recent

Market context for product code KFX

FDA has cleared 4 devices under product code KFX between 1982 and 1993, filed by 4 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

Top applicants under product code KFX

Recent clearances under product code KFX

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