Plus Orthopedics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
43
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K070928CERAMIC BALL HEADS, 28, 32 AND 36 MMAugust 1, 2007
K070731PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEMJuly 31, 2007
K070278POLARCUP DUAL MOBILITY SYSTEMApril 16, 2007
K063578PROMOS MODULAR SHOULDER SYSTEMMarch 2, 2007
K061362PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEMOctober 6, 2006
K032126PROMOS SHOULDERJanuary 8, 2004
K033763MODIFICATION TO SLIM GLIDING NAIL SYSTEMDecember 18, 2003
K032709MODULAR PLUS HIP STEMSeptember 23, 2003
K032548IP-XS COMPRESSION NAIL SYSTEMSeptember 10, 2003
K032215VKS/TC-PLUS REVISION KNEEAugust 8, 2003
K032052UC-PLUS SOLUTION UNICONDYLAR KNEEJuly 25, 2003
K031165PLUS ORTHOPEDICS CEMENTED HIP STEMJune 6, 2003
K030971MODIFICATION TO MODULAR PLUS REVISION STEMApril 24, 2003
K024134UNI HIP STEMJanuary 15, 2003
K023667RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEEDecember 24, 2002
K023416MODIFICATION TO VKS KNEE SYSTEMNovember 8, 2002
K022204VKS KNEE SYSTEMOctober 18, 2002
K022120MPF ACETABULAR CUP GENERATION 2July 24, 2002
K021714RT-PLUS PE INSERT CLAMPJune 21, 2002
K020298GALILEO CAS/NAV TKR SYSTEMMay 20, 2002