OMEGALIF

GUDID 00840916133221

OMEGA XP™ 9MM X 34MM X 8MM 0°

SPINAL ELEMENTS

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 00840916133221
• NIH Device Record Key: 5048c2d2-b4a4-4956-8482-bbe2e5be894d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMEGALIF
• Version Model Number: 72-00-093408-00
• Company DUNS: 004022104
• Company Name: SPINAL ELEMENTS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840916133221 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-22
• Device Publish Date: 2021-01-14

On-Brand Devices [OMEGALIF]

• 00840916155674: CORING TOOL 12mm
• 00840916155667: CORING TOOL 10mm
• 00840916155650: CORING TOOL 8mm
• 00840916124601: OmegaLIF 9mm Wide x 28mm Long x 8mm Collapsed Height x Parallel (8-11)
• 00840916124717: OmegaLIF 11mm Wide x 28mm Long x 13mm Collapsed Height x 11 degree Single Lordosis (13-16)
• 00840916124700: OmegaLIF 11mm Wide x 28mm Long x 11mm Collapsed Height x 11 degree Single Lordosis (11-14)
• 00840916124694: OmegaLIF 9mm Wide x 28mm Long x 13mm Collapsed Height x 11 degree Single Lordosis (13-16)
• 00840916124687: OmegaLIF 9mm Wide x 28mm Long x 12mm Collapsed Height x 11 degree Single Lordosis (12-15)
• 00840916124670: OmegaLIF 11mm Wide x 28mm Long x 11mm Collapsed Height x 4 degree Single Lordosis (11-14)
• 00840916124663: OmegaLIF 9mm Wide x 28mm Long x 11mm Collapsed Height x 4 degree Single Lordosis (11-14)
• 00840916124656: OmegaLIF 11mm Wide x 28mm Long x 9mm Collapsed Height x 4 degree Single Lordosis (9-12)
• 00840916124649: OmegaLIF 9mm Wide x 28mm Long x 9mm Collapsed Height x 4 degree Single Lordosis (9-12)
• 00840916124632: OmegaLIF 11mm Wide x 28mm Long x 12mm Collapsed Height x 11 degree Single Lordosis (12-15)
• 00840916124625: OmegaLIF 11mm Wide x 28mm Long x 8mm Collapsed Height x Parallel (8-11)
• 00840916124618: OmegaLIF 9mm Wide x 28mm Long x 10mm Collapsed Height x Parallel (10-13)
• 00840916155582: OmegaLIF offset inserter shaft – Long
• 00840916155575: OmegaLIF offset inserter shaft – Short
• 00840916142278: OmegaLIF IRRIGATION DILATOR
• 00840916142261: OmegaLIF AXIAL BREAKDOWN KNOB
• 00840916142254: OmegaLIF Instrument Tray Case
• 00840916142247: OmegaLIF T-HANDLE TRIAL
• 00840916142230: OmegaLIF T-HANDLE INSERTER ASSY
• 00840916142223: OmegaLIF REMOVAL TOOL
• 00840916142216: Omega LLIF Expanding Trial
• 00840916142209: Omega LLIF Expanding Trial
• 00840916133269: OMEGA XP™ 9MM X 34MM X 11MM 8° C
• 00840916133252: OMEGA XP™ 9MM X 34MM X 11MM 3° C
• 00840916133245: OMEGA XP™ 9MM X 34MM X 10MM 3° C
• 00840916133238: OMEGA XP™ 9MM X 34MM X 9MM 3° C
• 00840916133221: OMEGA XP™ 9MM X 34MM X 8MM 0°
• 00840916162160: TORQUE PALM AO HANDLE
• 00840916148546: TORQUE PALM AO INTERNAL ADAPTER