LTO — Spacer, Cement Class III

FDA Device Classification

FDA product code LTO covers "Spacer, Cement", a Class III medical device regulated under 21 CFR 888.3320. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants.

Classification Details

Product Code
LTO
Device Class
Class III
Regulation Number
888.3320
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes