Devices

AMENDIA Omega Lumbar Interbody Fusion Device

Model / Serial
Lot Number 140760
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
US Distribution to the states of : FL, GA, NC, PA and CO
Product Description
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
Manufacturer
Spinal Elements
1 Event
- Recall of AMENDIA Omega Lumbar Interbody Fusion Device

Manufacturer

Spinal Elements

Manufacturer Address
Spinal Elements, 1755 W Oak Pkwy, Marietta GA 30062-2260
Manufacturer Parent Company (2017)
Spinal Elements
Source
USFDA

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