MJT — Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented Class III

FDA Device Classification

FDA product code MJT covers "Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MJT
Device Class
Class III
Regulation Number
Submission Type
Review Panel
OR
Medical Specialty
Unknown
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K990712howmedica osteonicsOSTEONICS SOLAR SHOULDER BIPOLAR SYSTEMJuly 20, 1999
K982418endotecBUECHEL-PAPPAS MODULAR SALVAGE STEMApril 29, 1999
K960363biometBIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101February 18, 1997