Spinal Solutions, LLC

FDA Regulatory Profile

Summary

Total Recalls
11
510(k) Clearances
1
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1157-2013Class IIAPLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - March 8, 2013
Z-1415-2013Class II12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mmFebruary 20, 2013
Z-1413-2013Class II50 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a variety of spinal fixationFebruary 20, 2013
Z-1418-2013Class IIFang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety of spinaFebruary 20, 2013
Z-1417-2013Class IICopperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, Large NFebruary 20, 2013
Z-1412-2013Class II40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixationFebruary 20, 2013
Z-1409-2013Class II45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a variety of spinal fixatiFebruary 20, 2013
Z-1414-2013Class II60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a variety of spinal fixationFebruary 20, 2013
Z-1410-2013Class II50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of spinal fixatiFebruary 20, 2013
Z-1411-2013Class IISet Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a variety of spinal fixationFebruary 20, 2013
Z-1416-2013Class II14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9mm 7 deg 14 x 11 x 10February 20, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K110633LANCER PEDICLE SCREW SYSTEMDecember 15, 2011