KYK — Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite Class II

FDA Device Classification

FDA product code KYK covers "Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite", a Class II medical device regulated under 21 CFR 888.3500. 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
KYK
Device Class
Class II
Regulation Number
888.3500
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K880826johnson and johnson professionalsMICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEMMarch 14, 1988
K871118depuyMODIFIED TOWNLEY UNICONDYLAR KNEEApril 6, 1987
K851341depuySYNATOMIC VARIABLE FIT TIBIAL PLATEAUJuly 15, 1985