Xenon Pedicle Screw System

GUDID 00844856077522

Polyaxial Screw 4.5MM, 80MM

ALPHATEC SPINE, INC.

Bone-screw internal spinal fixation system

• Primary Device ID: 00844856077522
• NIH Device Record Key: a2d00af3-8fab-4ea1-8bf2-4555703795d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xenon Pedicle Screw System
• Version Model Number: 12VFP45-80
• 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
• 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
• 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: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 4.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856077522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111634

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

[00844856077522]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-24

On-Brand Devices [Xenon Pedicle Screw System]

• 00844856078383: Set Screw, Standard
• 00844856078376: Set Screw, Large (for 8.0mm screw)
• 00844856077881: Polyaxial Screw 7.0MM, 80MM
• 00844856077874: Polyaxial Screw 7.0MM, 75MM
• 00844856077867: Polyaxial Screw 7.0MM, 70MM
• 00844856077850: Polyaxial Screw 7.0MM, 65MM
• 00844856077843: Polyaxial Screw 7.0MM, 60MM
• 00844856077836: Polyaxial Screw 7.0MM, 55MM
• 00844856077829: Polyaxial Screw 7.0MM, 50MM
• 00844856077812: Polyaxial Screw 7.0MM, 45MM
• 00844856077805: Polyaxial Screw 7.0MM, 40MM
• 00844856077799: Polyaxial Screw 7.0MM, 35MM
• 00844856077782: Polyaxial Screw 7.0MM, 30MM
• 00844856077775: Polyaxial Screw 7.0MM, 25MM
• 00844856077768: Polyaxial Screw 6.2MM, 80MM
• 00844856077751: Polyaxial Screw 6.2MM, 75MM
• 00844856077744: Polyaxial Screw 6.2MM, 70MM
• 00844856077737: Polyaxial Screw 6.2MM, 65MM
• 00844856077720: Polyaxial Screw 6.2MM, 60MM
• 00844856077713: Polyaxial Screw 6.2MM, 55MM
• 00844856077706: Polyaxial Screw 6.2MM, 50MM
• 00844856077690: Polyaxial Screw 6.2MM, 45MM
• 00844856077683: Polyaxial Screw 6.2MM, 40MM
• 00844856077676: Polyaxial Screw 6.2MM, 35MM
• 00844856077669: Polyaxial Screw 4.5MM, 30MM
• 00844856077652: Polyaxial Screw 6.2MM, 25MM
• 00844856077645: Polyaxial Screw 5.5MM, 80MM
• 00844856077638: Polyaxial Screw 5.5MM, 75MM
• 00844856077621: Polyaxial Screw 5.5MM, 70MM
• 00844856077614: Polyaxial Screw 5.5MM, 65MM
• 00844856077607: Polyaxial Screw 5.5MM, 60MM
• 00844856077591: Polyaxial Screw 5.5MM, 55MM
• 00844856077584: Polyaxial Screw 5.5MM, 50MM
• 00844856077577: Polyaxial Screw 5.5MM, 45MM
• 00844856077560: Polyaxial Screw 5.5MM, 40MM
• 00844856077553: Polyaxial Screw 5.5MM, 35MM
• 00844856077546: Polyaxial Screw 5.5MM, 30MM
• 00844856077539: Polyaxial Screw 4.5MM, 25MM
• 00844856077522: Polyaxial Screw 4.5MM, 80MM
• 00844856077515: Polyaxial Screw 4.5MM, 75MM
• 00844856077508: Polyaxial Screw 4.5MM, 70MM
• 00844856077492: Polyaxial Screw 4.5MM, 65MM
• 00844856077485: Polyaxial Screw 4.5MM, 60MM
• 00844856077478: Polyaxial Screw 4.5MM, 55MM
• 00844856077461: Polyaxial Screw 4.5MM, 50MM
• 00844856077454: Polyaxial Screw 4.5MM, 45MM
• 00844856077447: Polyaxial Screw 4.5MM, 40MM
• 00844856077430: Polyaxial Screw 4.5MM, 35MM
• 00844856077423: Polyaxial Screw 4.5MM, 30MM
• 00844856077416: Polyaxial Screw 4.5MM, 25MM