X Spine Systems Inc

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0127-2017Class IICalix T PEEK Lumbar System, TLIF TrialMay 17, 2016
Z-0125-2017Class IICalix P PEEK Lumbar System, PLIF TrialMay 17, 2016
Z-0126-2017Class IICalix T PEEK Lumbar System, TLIF RaspMay 17, 2016
Z-0124-2017Class IICalix P PEEK Lumbar System, PLIF RaspMay 17, 2016
Z-1823-2015Class IIFortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 AlexandersApril 7, 2015
Z-1512-2015Class IIXpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery cMarch 11, 2015
Z-2136-2014Class IISerrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion July 11, 2014