General Instrument

GUDID 00840180511596

LIF Trial, Rasped, 6 X 22 X 70, 10°, Hudson

ALPHATEC SPINE, INC.

Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial

• Primary Device ID: 00840180511596
• NIH Device Record Key: 0f8b8c16-e8f0-4390-9e8f-29a5c6df12a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: General Instrument
• Version Model Number: CI-11084-10-06227010
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• 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: false
• 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
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840180511596 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183705

FDA Product Code

• PHM: Intervertebral fusion device with bone graft, thoracic

Sterilization

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

[00840180511596]

Moist Heat or Steam Sterilization

[00840180511596]

Moist Heat or Steam Sterilization

[00840180511596]

Moist Heat or Steam Sterilization

[00840180511596]

Moist Heat or Steam Sterilization

[00840180511596]

Moist Heat or Steam Sterilization

[00840180511596]

Moist Heat or Steam Sterilization

[00840180511596]

Moist Heat or Steam Sterilization

[00840180511596]

Moist Heat or Steam Sterilization

[00840180511596]

Moist Heat or Steam Sterilization

[00840180511596]

Moist Heat or Steam Sterilization

[00840180511596]

Moist Heat or Steam Sterilization

[00840180511596]

Moist Heat or Steam Sterilization

[00840180511596]

Moist Heat or Steam Sterilization

[00840180511596]

Moist Heat or Steam Sterilization

[00840180511596]

Moist Heat or Steam Sterilization

[00840180511596]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-21
• Device Publish Date: 2022-10-13

On-Brand Devices [General Instrument]

• 00840180513156: Long D'Errico Nerve Root Retractor
• 00840180513149: Long Tube Variable Drill Guide
• 00840180512913: Axial Latching Handle
• 00840180512852: Straight Thoracic Probe, XL
• 00840180512814: Slap Hammer Impact Cap
• 00840180512784: Self Retaining Screwdriver
• 00840180512777: Pituitary Rongeur 5mm
• 00840180512760: Pituitary Rongeur 3mm
• 00840180512746: PLIF/TLIF Shucker
• 00840180512722: Slim Tap With Depth Marking, 6.5mm
• 00840180512715: Slim Tap With Depth Marking, 5.5mm
• 00840180512708: Slim Tap With Depth Marking, 4.5mm
• 00840180512654: Screw Adjuster, Quarter-Square
• 00840180512647: Serrated Endplate Scraper – 16mm
• 00840180512623: Trestle Luxe II DTS Inverted Handle
• 00840180512616: LIF Thin Cobb Elevator Straight 12mm
• 00840180512609: Plate Bender
• 00840180512456: Cervical Paddle Distractor
• 00840180512449: Rigid Ball Tip Probe With Single Digit Laser Marking
• 00840180512371: PLIF/TLIF Curette, Size 1, 45° Push
• 00840180512364: PLIF/TLIF Curette, Size 1, 45° Pull
• 00840180512296: 12mm Awl -Long Tube Drill Guide
• 00840180512289: Long Tube Fixed Drill Guide
• 00840180512272: Longer ALIF Teardrop Curette, Straight
• 00840180512265: Longer ALIF Teardrop Curette, Right/Left
• 00840180512258: Longer ALIF Teardrop Curette, Double Bend
• 00840180512241: Longer ALIF Osteotome, Straight
• 00840180512234: Longer ALIF Osteotome, Double Bend
• 00840180512227: Shorter Arsenal Taps, 5.5 MM, AO Connection
• 00840180512210: Shorter Arsenal Taps, 5.0 MM, AO Connection
• 00840180512203: Shorter Arsenal Taps, 4.5 MM, AO Connection
• 00840180512197: Shorter Arsenal Taps, 4.0 MM, AO Connection
• 00840180512180: Invictus Locking Poly Driver, Short, AO Backend
• 00840180512111: Cannulated Gearshift Slap Hammer
• 00840180512098: ALIF Distractor, Quarter-Square, 38 X 28 X 4 MM, 10°
• 00840180512081: ALIF Distractor, Quarter-Square, 34 X 24 X 4 MM, 10°
• 00840180512074: Longer ALIF Wedge Distractor, Bent
• 00840180512067: Longer ALIF Wedge Distractor, Straight
• 00840180512050: Longer ALIF Cup Curettes, Left Bend, Small
• 00840180512043: Longer ALIF Cup Curettes, Right Bend, Small
• 00840180512036: Longer ALIF Cup Curettes, Double Bend, Small
• 00840180512029: Longer ALIF Cup Curettes, Left Bend, Large
• 00840180512012: Longer ALIF Cup Curettes, Right Bend, Large
• 00840180512005: Longer ALIF Cup Curettes, Double-Bend, Large
• 00840180511992: Longer ALIF Double-Sided Endplate Scraper, Straight
• 00840180511985: Longer ALIF Double-Sided Endplate Scraper, Right/Left Bend
• 00840180511978: Longer ALIF Double-Sided Endplate Scraper, Double Bend
• 00840180511961: Longer ALIF Cobb, 22 MM, Double Bend, Inferior
• 00840180511954: Longer ALIF Cobb, 22 MM, Double Bend, Superior
• 00840180511947: ALL Retractor w/ Keel, 230mm, Left