International Medical Devices Database

Manufacturer Address
Spinal Elements, 1755 W Oak Pkwy, Marietta GA 30062-2260
Manufacturer Parent Company (2017)
Spinal Elements
Source
USFDA
1 Event
- Recall of AMENDIA Omega Lumbar Interbody Fusion Device

One device in the database

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

3 manufacturers with a similar name

Learn more about the data here

Spinal Elements, Inc

Manufacturer Address
Spinal Elements, Inc, 3115 Melrose Dr, Suite 200, Carlsbad CA 92010-6690
Source
USFDA

Amendia, Inc dba Spinal Elements

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

Spinal Elements, Inc

Manufacturer Address
Spinal Elements, Inc, 3115 Melrose Dr Suite 200, Carlsbad CA 92010-6690
Manufacturer Parent Company (2017)
Spinal Elements
Source
USFDA

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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