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
KFXClass II

Assembly, Thigh/Knee/Shank/Ankle/Foot, External

21 CFR 890.3500 / Physical Medicine
FDA source (opens on fda.gov)

KFX is the FDA product code for Assembly, Thigh/Knee/Shank/Ankle/Foot, External, a class II device type, regulated under 21 CFR 890.3500. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
KFX
Device name
Assembly, Thigh/Knee/Shank/Ankle/Foot, External
Regulation
21 CFR 890.3500
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
3

Clearances, product code KFX

By decision year
4 clearances under product code KFX with a decision year between 1982 and 1993, 1983 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KFX by decision year
YearClearances
19821
19832
19931

Applicants with the most clearances

Product code KFX
Applicants holding the most 510(k) clearances under product code KFX
ApplicantClearances
American Mcgaw1
Besco Financial Service1
Ipos Luneburg1
Vascutech, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code