510(k) K071914 ยท NKB Thoracolumbosacral Pedicle Screw System
MERCURY SPINAL SYSTEM
| Applicant | Spinal Elements, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Oct 12, 2007 |
| Received | Jul 11, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071914
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2015 | Spinal Elements, Inc Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the n Terminated |
NKB | None listed |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod,
Part Number: 60100-030.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | None listed |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod,
Part Number: 60100-040.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | None listed |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod,
Part Number: 60100-050.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | None listed |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod,
Part Number: 60100-060.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | None listed |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod,
Part Number: 60100-070.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | None listed |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod,
Part Number: 60100-080.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | None listed |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod,
Part Number: 60100-090.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | None listed |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod,
Part Number: 60100-100.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | None listed |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod,
Part Number: 60100-110.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | None listed |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod,
Part Number: 60100-120.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | None listed |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 30mm Straight Rod,
Part Number: 60101-030.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | None listed |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 40mm Straight Rod,
Part Number: 60101-040.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | None listed |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 50mm Straight Rod,
Part Number: 60101-050.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | None listed |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 60mm Straight Rod,
Part Number: 60101-060.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | None listed |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 70mm Straight Rod,
Part Number: 60101-070.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | None listed |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 80mm Straight Rod,
Part Number: 60101-080.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | None listed |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 90mm Straight Rod,
Part Number: 60101-090.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | None listed |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 100mm Straight Rod,
Part Number: 60101-100.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | None listed |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 110mm Straight Rod,
Part Number: 60101-110.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | None listed |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 120mm Straight Rod,
Part Number: 60101-120.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | None listed |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 400mm Straight Rod,
Part Number: 60101-400.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.