Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal

What Is This Device?

Call for PMAs 12/26/96 (61 FR 50710 (9/27/96))

How Is KWB Classified?

Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal is FDA product code KWB, Class 3, 21 CFR 888.3370.

What Does It Take to Sell It in the United States?

A premarket approval is required: the Class 3 route, granted on clinical evidence rather than on equivalence to an existing device. No approval under this code names a Chinese applicant.