Illico FS Facet Fixation System

GUDID 00844856068674

FACET LAG SCREW, 4.5mm X 35mm

ALPHATEC SPINE, INC.

Bone-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00844856068674
• NIH Device Record Key: e0257b3d-9dfc-4c3e-a10e-9d0e2c0a9445
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Illico FS Facet Fixation System
• Version Model Number: 74345-35
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Dimensions

• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 4.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856068674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123218

FDA Product Code

• MRW: SYSTEM, FACET SCREW SPINAL DEVICE

Sterilization

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

[00844856068674]

Moist Heat or Steam Sterilization

[00844856068674]

Moist Heat or Steam Sterilization

[00844856068674]

Moist Heat or Steam Sterilization

[00844856068674]

Moist Heat or Steam Sterilization

[00844856068674]

Moist Heat or Steam Sterilization

[00844856068674]

Moist Heat or Steam Sterilization

[00844856068674]

Moist Heat or Steam Sterilization

[00844856068674]

Moist Heat or Steam Sterilization

[00844856068674]

Moist Heat or Steam Sterilization

[00844856068674]

Moist Heat or Steam Sterilization

[00844856068674]

Moist Heat or Steam Sterilization

[00844856068674]

Moist Heat or Steam Sterilization

[00844856068674]

Moist Heat or Steam Sterilization

[00844856068674]

Moist Heat or Steam Sterilization

[00844856068674]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-01

On-Brand Devices [Illico FS Facet Fixation System]

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• 00844856068704: FACET LAG SCREW, 50mm X 35mm
• 00844856068698: FACET LAG SCREW, 4.5mm X 45mm
• 00844856068681: FACET LAG SCREW, 4.5mm X 40mm
• 00844856068674: FACET LAG SCREW, 4.5mm X 35mm
• 00844856068667: FACET LAG SCREW, 4.5mm X 30mm
• 00844856068650: FACET LAG SCREW, 4.5mm X 25mm
• 00844856068643: FACET SCREW, 5.0mm X 40mm
• 00844856068636: FACET SCREW, 5.0mm X 35mm
• 00844856068629: FACET SCREW, 4.5mm X 45mm
• 00844856068612: FACET SCREW, 4.5mm X 40mm
• 00844856068605: FACET SCREW, 4.5mm X 35mm
• 00844856068599: FACET SCREW, 4.5mm X 30mm
• 00844856068582: FACET SCREW, 4.5mm X 25mm