General Instruments

GUDID 00840180503553

5x12x14mm, 5-deg Pegasus Trials w/Thru Hole

ALPHATEC SPINE, INC.

Spinal implant trial

• Primary Device ID: 00840180503553
• NIH Device Record Key: 5f8fb584-8d78-41c0-ac1f-7ecd0e089946
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: General Instruments
• Version Model Number: CI-10116-5M
• 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

Device Dimensions

• Angle: 5 degree
• Length: 16 Millimeter
• Height: 5 Millimeter
• Width: 14 Millimeter
• Angle: 5 degree
• Length: 16 Millimeter
• Height: 5 Millimeter
• Width: 14 Millimeter
• Angle: 5 degree
• Length: 16 Millimeter
• Height: 5 Millimeter
• Width: 14 Millimeter
• Angle: 5 degree
• Length: 16 Millimeter
• Height: 5 Millimeter
• Width: 14 Millimeter
• Angle: 5 degree
• Length: 16 Millimeter
• Height: 5 Millimeter
• Width: 14 Millimeter
• Angle: 5 degree
• Length: 16 Millimeter
• Height: 5 Millimeter
• Width: 14 Millimeter
• Angle: 5 degree
• Length: 16 Millimeter
• Height: 5 Millimeter
• Width: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840180503553 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150913

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

[00840180503553]

Moist Heat or Steam Sterilization

[00840180503553]

Moist Heat or Steam Sterilization

[00840180503553]

Moist Heat or Steam Sterilization

[00840180503553]

Moist Heat or Steam Sterilization

[00840180503553]

Moist Heat or Steam Sterilization

[00840180503553]

Moist Heat or Steam Sterilization

[00840180503553]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-16
• Device Publish Date: 2021-08-06

On-Brand Devices [General Instruments]

• 00811801037276: Penfield 4 w/Larger Handle
• 00811801039973: Ball Tip Probe, Rod Holder
• 00811801038204: Heavy Guidewire Comb
• 00840180501221: SHARP COBB, UP-ANGLED 22MM
• 00840180501214: SHARP COBB, STRAIGHT 22MM
• 00840180501207: SHARP COBB, DOWN-ANGLED 18MM
• 00840180501191: SHARP COBB, UP-ANGLED 18MM
• 00840180501184: SHARP COBB, STRAIGHT 18MM
• 00840180501177: SHARP COBB, UP-ANGLED 12MM
• 00840180501160: SHARP COBB, STRAIGHT 12MM
• 00840180501153: 5mm Extra Wide Saddle Removal Tool
• 00840180501146: Larger ALIF Tamp w/Teeth
• 00840180501139: Size 4 Curette - Down 60Deg
• 00840180501122: Size 2 Curette - 15Deg Up
• 00840180501115: Closed Tulip Screwdriver
• 00840180501108: Battalion, LLIF, 4th Blade w/ Large Handle, 12mm x 230mm
• 00840180501092: Battalion, LLIF, 4th Blade w/ Large Handle, 12mm x 190mm
• 00840180501085: Battalion, LLIF, 4th Blade w/ Large Handle, 8mm x 230mm
• 00840180501078: Battalion, LLIF, 4th Blade w/ Large Handle, 8mm x 190mm
• 00840180501061: Tamp w/ Center Pin, Straight
• 00840180501054: Suction Cobb
• 00840180501047: LIF Cup Curette, Offset Up Angled, Size 0
• 00840180501030: Long Plate Holder
• 00840180501023: Set Screw Inserter - 4" shorter
• 00840180501016: Modular Compress-Distract Rack - Diener QC
• 00840180501009: Stab and Grab Screwdriver - Short, no clip
• 00840180500996: 90 degree Head Turner - Extra long, large diameter
• 00840180500989: Slap Hammer Adapter, Large Battalion Backend
• 00840180500972: Slap Hammer Adapter, 1/4" Sq
• 00840180500965: ACDF Nerve Hook
• 00840180500958: Gear Shift Probe w/Radel Ball Handle
• 00840180500941: STIRRUP SCRAPER, UP-ANGLED DOUBLE SIDE - 18MM
• 00840180500934: STIRRUP SCRAPER, UP-ANGLED DOUBLE SIDE - 16MM
• 00840180500927: STIRRUP SCRAPER, UP-ANGLED DOUBLE SIDE - 14MM
• 00840180500910: STIRRUP SCRAPER, UP-ANGLED DOUBLE SIDE - 12MM
• 00840180500903: STIRRUP SCRAPER, SINGLE SIDE - 18MM
• 00840180500897: STIRRUP SCRAPER, SINGLE SIDE - 16MM
• 00840180500880: STIRRUP SCRAPER, SINGLE SIDE - 14MM
• 00840180500873: STIRRUP SCRAPER, SINGLE SIDE - 12MM
• 00840180500866: STIRRUP SCRAPER, UP-ANGLED - 18MM
• 00840180500859: STIRRUP SCRAPER, UP-ANGLED - 16MM
• 00840180500842: STIRRUP SCRAPER, UP-ANGLED - 14MM
• 00840180500835: STIRRUP SCRAPER, UP-ANGLED - 12MM
• 00840180500828: STIRRUP SCRAPER - 18MM
• 00840180500811: STIRRUP SCRAPER - 16MM
• 00840180500804: STIRRUP SCRAPER - 14MM
• 00840180500798: STIRRUP SCRAPER - 12MM
• 00840180500781: Distractor, 10x5x25mm-15°
• 00840180500774: Distractor, 9x5x25mm-15°
• 00840180500767: Distractor, 8x5x25mm-15°