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 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
- 1993
- 1983
- 1982
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.