Spinal Solutions, LLC
FDA Regulatory Profile
Spinal Solutions, LLC appears in FDA public data with 11 recalls, 1 510(k) clearance, 2 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1157-2013, Class II) was initiated on March 8, 2013. Its most recent 510(k) clearance was granted on December 15, 2011.
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1157-2013 | Class II | APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - | March 8, 2013 |
| Z-1415-2013 | Class II | 12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mm | February 20, 2013 |
| Z-1410-2013 | Class II | 50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of spinal fixati | February 20, 2013 |
| Z-1412-2013 | Class II | 40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation | February 20, 2013 |
| Z-1413-2013 | Class II | 50 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a variety of spinal fixation | February 20, 2013 |
| Z-1418-2013 | Class II | Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety of spina | February 20, 2013 |
| Z-1417-2013 | Class II | Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, Large N | February 20, 2013 |
| Z-1409-2013 | Class II | 45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a variety of spinal fixati | February 20, 2013 |
| Z-1414-2013 | Class II | 60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a variety of spinal fixation | February 20, 2013 |
| Z-1416-2013 | Class II | 14 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 10 | February 20, 2013 |
| Z-1411-2013 | Class II | Set Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a variety of spinal fixation | February 20, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K110633 | LANCER PEDICLE SCREW SYSTEM | December 15, 2011 |