510(k) K110633 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
LANCER PEDICLE SCREW SYSTEM
| Applicant | Spinal Solutions, LLC, Round Rock TX, US |
| Decision | Substantially Equivalent, Dec 15, 2011 |
| Received | Mar 4, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110633
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2013 | Spinal Solutions, LLC 45 mm Screw, Item #BG7045
Product Usage:
Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and Terminated |
MNI | None listed |
| May 27, 2013 | Spinal Solutions, LLC 50 mm Screw, Item #BG7050
Product Usage:
Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and Terminated |
MNI | None listed |
| May 27, 2013 | Spinal Solutions, LLC Set Screw, Item #BG3010
Product Usage:
Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and su Terminated |
MNI | None listed |
| May 27, 2013 | Spinal Solutions, LLC 40 mm Rod, Item #BG1640
Product Usage:
Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and su Terminated |
MNI | None listed |
| May 27, 2013 | Spinal Solutions, LLC 50 mm Rod, Item #BG1650
Product Usage:
Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and su Terminated |
MNI | None listed |
| May 27, 2013 | Spinal Solutions, LLC 60 mm Rod, Item #BG1660
Product Usage:
Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and su Terminated |
MNI | None listed |
| May 27, 2013 | Spinal Solutions, LLC 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
12mm x 27mm x 13mm
12mm x 27mm x 14mm
Product Usage:
Spinal Solutions distributes a variety of spina Terminated |
MNI | None listed |
| May 27, 2013 | Spinal Solutions, LLC 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 10mm 7 deg
14 x 11 x 11mm 7 deg
14 x 11 x 12mm 7 deg
Product Usage:
Spinal Solutions distributes a var Terminated |
MNI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.