KTX — Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented Class II

FDA Device Classification

FDA product code KTX covers "Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented", a Class II medical device regulated under 21 CFR 888.3490. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants.

Classification Details

Product Code
KTX
Device Class
Class II
Regulation Number
888.3490
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes