KMC — Prosthesis, Hip, Semi-Constrained, Composite/Metal Class II

FDA Device Classification

FDA product code KMC covers "Prosthesis, Hip, Semi-Constrained, Composite/Metal", a Class II medical device regulated under 21 CFR 888.3340. Submissions are reviewed by the Orthopedic 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
KMC
Device Class
Class II
Regulation Number
888.3340
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K936044zimmerENHANCED MODULAR AUSTIN MOORE HIPApril 26, 1994
K853524intermedics orthopedicsAPR REVISION HIP PROSTHESIS, FEMORAL COMPONENTNovember 22, 1985
K853259biometMALLORY/HEAD TOTAL HIP SYSTEMNovember 1, 1985