HRZ — Prosthesis, Knee, Hinged (Metal-Metal) Class III

FDA Device Classification

FDA product code HRZ covers "Prosthesis, Knee, Hinged (Metal-Metal)", a Class III medical device regulated under 21 CFR 888.3480. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants.

Classification Details

Product Code
HRZ
Device Class
Class III
Regulation Number
888.3480
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Definition

PMAs to be filed by 12/26/96 (61 FR 50710 (9/27/96))