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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 Recall
Open, Classified ·Spinal Elements·Product code MAX·April 16, 2018

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 Recall
Terminated ·Spinal Elements, Inc·Product code NKB·April 17, 2009

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 Recall
Terminated ·Spinal Elements, Inc·Product code NKB·April 17, 2009

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 Recall
Terminated ·Spinal Elements, Inc·Product code NKB·April 17, 2009

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 Recall
Terminated ·Spinal Elements, Inc·Product code NKB·April 17, 2009

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 Recall
Terminated ·Spinal Elements, Inc·Product code NKB·April 17, 2009

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 Recall
Terminated ·Spinal Elements, Inc·Product code NKB·April 17, 2009

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 Recall
Terminated ·Spinal Elements, Inc·Product code NKB·April 17, 2009

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 Recall
Terminated ·Spinal Elements, Inc·Product code NKB·April 17, 2009

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.

FDA Recall
Terminated ·Spinal Elements, Inc·Product code NKB·April 17, 2009

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 Recall
Terminated ·Spinal Elements, Inc·Product code MAX·December 18, 2014

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 Recall
Terminated ·Spinal Elements, Inc·Product code NKB·April 17, 2009

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 Recall
Terminated ·Spinal Elements, Inc·Product code NKB·April 17, 2009

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 Recall
Terminated ·Spinal Elements, Inc·Product code NKB·April 17, 2009

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 non-cervical spine. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Lordosed rods are pre-curved to better fit the patient anatomy.

FDA Recall
Terminated ·Spinal Elements, Inc·Product code NKB·April 9, 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 Recall
Terminated ·Spinal Elements, Inc·Product code NKB·April 17, 2009

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 Recall
Terminated ·Spinal Elements, Inc·Product code NKB·April 17, 2009

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.

FDA Recall
Terminated ·Spinal Elements, Inc·Product code NKB·April 17, 2009

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.

FDA Recall
Terminated ·Spinal Elements, Inc·Product code NKB·April 17, 2009

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 Recall
Terminated ·Spinal Elements, Inc·Product code NKB·April 17, 2009