510(k) Report

Devices descending from K961304

5 later devices reach Aura Hip System Cemented Femoral Stem/Cemented Long Femoral Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012493Acumatch C-Series Cemented Femoral Component, Model Size 0Exactech, Inc.20010—
+1K001335Acumatch L-Series Cemented Femoral Stem, Model L-Series CementedExactech, Inc.20004—
+2K052787Acumatch 12/14 C-Series Cemented Femoral Stems (Size 1-6), Acumatch 12/14 L-Series…Exactech, Inc.20052—
+3K083392Novation 12/14 Cemented Femoral StemsExactech, Inc.200811
+4K090764Novation CFS Press-Fit and Cemented StemsExactech, Inc.20090—