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Stelkast Co

13 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is in recall (Z-0970-2015)Stelkast Co2015-01-14
SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, os recall (Z-2136-2013)Stelkast Co2013-09-03
Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474- recall (Z-1066-2013)Stelkast Co2013-04-07
Stelkast Unicondylar Knee Femoral Component SC2462-1. Used for moderate joint impairment f recall (Z-0371-2010)Stelkast Co2009-11-20
Dual Taper Wedge Pressed Fit Femoral Component. The Dual Taper Wedge is a single use devic recall (Z-1073-2009)Stelkast Co2009-03-31
Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC143 recall (Z-0664-2009)Stelkast Co2009-01-28
Proven Cemented Semi-Constrained Total Knee. Part number SC1591. The size is 38 and the th recall (Z-0308-2009)Stelkast Co2008-11-25
StelKast Proven Knee System - Tibial Half Block Augmentation and Screw. Part Number SC2287 recall (Z-0479-2008)Stelkast Co2008-01-23
StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-2-5, S recall (Z-0480-2008)Stelkast Co2008-01-23
StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-3-5, S recall (Z-0481-2008)Stelkast Co2008-01-23
StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-4-5, S recall (Z-0482-2008)Stelkast Co2008-01-23
StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number: SC2287-5-5, recall (Z-0483-2008)Stelkast Co2008-01-23
Proven Porous CR Femur. Implantable orthopedic device recall (Z-0496-05)Stelkast Co2005-02-03

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Every clearance here is in the API, with alerts when new ones post.