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MBV — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer Class II

FDA Device Classification

Classification Details

Product Code
MBV
Device Class
Class II
Regulation Number
888.3560
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K010212biometOFFSET TIBIAL TRAYFebruary 14, 2001
K884824richards medical coTRICON-M TOTAL KNEE SYSTEMNovember 21, 1989
K873429protekFREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEEOctober 28, 1987
K853730protekFREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REPFebruary 18, 1986
K833200richards medical coTRICON M TOTAL KNEE SYSTEMNovember 29, 1983
K831441depuyPOROCOAT FREEMAN/SAMUELSON TOTAL KNEESeptember 1, 1983
K832302advanced biosearch assnMARK I TOTAL KNEE SYS. ARTHROPLASTYAugust 16, 1983
K830726advanced biosearch assnMARK I & II TOTAL KNEE REPLACE. SYSJune 22, 1983
K823837richard medical equipRMC TOTAL KNEE SYSTEMMarch 29, 1983
K830408depuyFREEMAN/SAMUELSON TOTAL KNEEFebruary 24, 1983
K822583richard medical equipTOTAL KNEE SYSTEMOctober 4, 1982
K802921depuyICLH TIBIAL PLATEAUJanuary 8, 1981
K780904depuyKNEE, TOTAL, FEMORAL & TIBIALJune 22, 1978
K780284depuyTIBIAL PLATEUMarch 15, 1978