Stelkast Company - FDA 510(k) Cleared Devices
Recent clearances: EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM, CROSS-OVER ACETABULAR SHELL & LINER, EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM
40
Total
37
Cleared
0
Denied
FDA 510(k) Regulatory Record - Stelkast Company Orthopedic ✕
40 devices
Cleared
Aug 05, 2013
EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE...
Orthopedic
319d
Cleared
Oct 09, 2012
CROSS-OVER ACETABULAR SHELL & LINER
Orthopedic
29d
Cleared
Mar 24, 2011
EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM
Orthopedic
449d
Cleared
Jun 06, 2008
PROVEN STEM EXTENDER
Orthopedic
14d
Cleared
Jan 18, 2007
PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT
Orthopedic
87d
Cleared
Oct 17, 2005
PROVEN REVISION MODULAR TIBIAL TRAY
Orthopedic
88d
Cleared
Mar 12, 2004
STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD
Orthopedic
84d
Cleared
Nov 13, 2003
STELKAST UNICONDYLAR KNEE SYSTEM
Orthopedic
64d
Cleared
Oct 10, 2003
PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT
Orthopedic
112d
Cleared
Sep 22, 2003
PROCLASS PRESS FIT HIP STEM
Orthopedic
75d
Cleared
Mar 25, 2003
PROVEN MODULAR TIBIAL TRAY
Orthopedic
29d
Cleared
Jul 09, 2002
PROVEN MODULAR POSTERIOR STABILIZED FEMORAL
Orthopedic
29d
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