26 results
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33ms
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Sources: EU EUDAMED, US FDA
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AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Device is designed for use in intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. The ¿LIF features a self-locking expansion mechanism that is infinitely adjustable, along with a bullet nose design for minimal impaction and ease of insertion. The ¿LIF is streamlined and available in various implant sizes to fit a variety of patient anatomies and surgical preferences
FDA Enforcement
Class II
·Ongoing·Spinal Elements·May 30, 2018
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.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
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.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.
FDA Enforcement
Class II
·Terminated·Spinal Elements, Inc·January 14, 2015
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.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
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.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
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.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
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.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
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.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
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.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
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.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
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.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
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.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
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.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
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.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
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.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
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.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
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.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
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.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
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.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013