KWR

Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented

Product code: KWR
Device name: Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented
Device class: Class 3
21 CFR: 21 CFR 888.3640
Medical specialty: Orthopedic
Marketing pathway: PMA
Flag: Implant

FDA classification definition

Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: KWR

Classification and pathway per current FDA publications. Data from openFDA (CC0).