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Fx Solutions

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2469-2018Class IIFx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce aJune 4, 2018
Z-2468-2018Class IIFx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produceJune 4, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K163669Humeris ShoulderMay 17, 2017
K162455Humelock Reversed ShoulderJanuary 17, 2017
K150488Humelock II Reversible Shoulder SystemNovember 13, 2015
K143721PRCT2August 27, 2015
K140071HUMELOCK II CEMENTED SHOULDER SYSTEMJuly 28, 2014
K130759HUMELOCK II CEMENTLESS SHOULDER SYSTEMNovember 9, 2013
K123814HUMELOCK II CEMENTED SHOULDER SYSTEMAugust 13, 2013
K111097HUMELOCK CEMENTED SHOULDER PROSTHESISNovember 9, 2011