Omni

GUDID 00840916111489

5.0mm x 45mm Lo-Top Talon Screw

SPINAL ELEMENTS

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840916111489
• NIH Device Record Key: dd18cb82-260e-4f50-ab0c-5f724e35dcf2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omni
• Version Model Number: ST05045
• 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: false
• 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	00840916111489 [Primary]

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[00840916111489]

Moist Heat or Steam Sterilization

[00840916111489]

Moist Heat or Steam Sterilization

[00840916111489]

Moist Heat or Steam Sterilization

[00840916111489]

Moist Heat or Steam Sterilization

[00840916111489]

Moist Heat or Steam Sterilization

[00840916111489]

Moist Heat or Steam Sterilization

[00840916111489]

Moist Heat or Steam Sterilization

[00840916111489]

Moist Heat or Steam Sterilization

[00840916111489]

Moist Heat or Steam Sterilization

[00840916111489]

Moist Heat or Steam Sterilization

[00840916111489]

Moist Heat or Steam Sterilization

[00840916111489]

Moist Heat or Steam Sterilization

[00840916111489]

Moist Heat or Steam Sterilization

[00840916111489]

Moist Heat or Steam Sterilization

[00840916111489]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-03-25
• Device Publish Date: 2017-07-10

On-Brand Devices [Omni]

• 00840916111489: 5.0mm x 45mm Lo-Top Talon Screw
• 00840916111472: 5.0mm x 40mm Lo-Top Talon Screw
• 00840916109950: 7.0mm x 45mm Reduction Tab Screw
• 00840916108212: 120mm 360 Flex Bullet Rod
• 00840916108182: 110mm 360 Flex Bullet Rod
• 00840916108168: 100mm 360 Flex Bullet Rod
• 00840916110598: 5.5mm x 120mm Straight Rod (00607-120)
• 00840916110192: 4.5mm x 35mm Polyaxial Screw
• 00840916110185: 4.5mm x 30mm Polyaxial Screw
• 00840916108601: 6.0x55mm Long Cannulated Screw
• 00840916108595: 6.0x50mm Long Cannulated Screw
• 00840916108564: 6.0x35mm Long Cannulated Screw
• 00840916111045: 5.5mm x 30mm Prebent Rod
• 00840916111038: 60-75 (Lg) Cross Connector
• 00840916110765: 50mm Barrel 5.5mm Pre-Bent Rod
• 00840916110703: 35mm Flex 5.5mm Pre-Bent Rod
• 00840916110680: 5.5x600mm Straight Rod
• 00840916110673: 5.5x500mm Straight Rod
• 00840916110611: 5.5mm x 140mm Straight Rod (00607-140)
• 00840916110604: 5.5mm x 130mm Straight Rod
• 00840916110581: 5.5mm x 110mm Straight Rod
• 00840916110574: 5.5mm x 100mm Straight Rod (00607-100)
• 00840916110482: Lock Screw Assembly
• 00840916110215: 4.5mm x 45mm Polyaxial Screw
• 00840916110161: 4.0mm x 40mm Polyaxial Screw
• 00840916109820: Keyed Bullet Rod 30mm
• 00840916108922: 95mm 360 Flex Pre-Bent Bullet
• 00840916108915: 95mm 360 Flex Bullet Rod
• 00840916108908: 90mm Keyed Bullet Rod
• 00840916108892: 90mm 360 Flex Pre-Bent Bullet
• 00840916108885: 90mm 360 Flex Bullet Rod
• 00840916108878: 85mm 360 Flex Pre-Bent Bullet
• 00840916108861: 85mm 360 Flex Bullet Rod
• 00840916108854: 80mm Keyed Bullet Rod
• 00840916108847: 80mm 360 Flex Pre-Bent Bullet
• 00840916108830: 80mm 360 Flex Bullet Rod
• 00840916108823: 8.0 x 50mm Long Cannulated Screw
• 00840916108816: 8.0 x 45mm Long Cannulated Screw
• 00840916108809: 8.0 x 40mm Long Cannulated Screw
• 00840916108793: 8.0 x 35mm Long Cannulated Screw
• 00840916108755: 70mm Keyed Bullet Rod
• 00840916108748: 70mm 360 Flex Pre-Bent Bullet
• 00840916108731: 70mm 360 Flex Bullet Rod
• 00840916108724: 7.0x55mm Long Cannulated Screw
• 00840916108717: 7.0x50mm Long Cannulated Screw
• 00840916108700: 7.0x45mm Long Cannulated Screw
• 00840916108694: 7.0x40mm Long Cannulated Screw
• 00840916108687: 7.0x35mm Long Cannulated Screw
• 00840916108670: 70mm Bullet Rod
• 00840916108632: 60mm Keyed Bullet Rod