Trestle Luxe Anterior Cervical Plating System

GUDID 00844856068018

4.5mm Fixed Angle, Self-Tapping Hexalobe Screw, 10mm

ALPHATEC SPINE, INC.

Orthopaedic fixation plate kit, non-bioabsorbable, sterile

• Primary Device ID: 00844856068018
• NIH Device Record Key: cd880ab8-d356-4417-821b-b3e0ea124e5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trestle Luxe Anterior Cervical Plating System
• Version Model Number: 71545-10
• 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
• 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

• Length: 10 Millimeter
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856068018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102820

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

Moist Heat or Steam Sterilization

[00844856068018]

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 [Trestle Luxe Anterior Cervical Plating System]

• 00844856068179: 4.5mm Fixed Angle, Self-Tapping Hexalobe Screw, 26mm
• 00844856068162: 4.5mm Fixed Angle, Self-Tapping Hexalobe Screw, 25mm
• 00844856068155: 4.5mm Fixed Angle, Self-Tapping Hexalobe Screw, 24mm
• 00844856068148: 4.5mm Fixed Angle, Self-Tapping Hexalobe Screw, 23mm
• 00844856068131: 4.5mm Fixed Angle, Self-Tapping Hexalobe Screw, 22mm
• 00844856068124: 4.5mm Fixed Angle, Self-Tapping Hexalobe Screw, 21mm
• 00844856068117: 4.5mm Fixed Angle, Self-Tapping Hexalobe Screw, 20mm
• 00844856068100: 4.5mm Fixed Angle, Self-Tapping Hexalobe Screw, 19mm
• 00844856068094: 4.5mm Fixed Angle, Self-Tapping Hexalobe Screw, 18mm
• 00844856068087: 4.5mm Fixed Angle, Self-Tapping Hexalobe Screw, 17mm
• 00844856068070: 4.5mm Fixed Angle, Self-Tapping Hexalobe Screw, 16mm
• 00844856068063: 4.5mm Fixed Angle, Self-Tapping Hexalobe Screw, 15mm
• 00844856068056: 4.5mm Fixed Angle, Self-Tapping Hexalobe Screw, 14mm
• 00844856068049: 4.5mm Fixed Angle, Self-Tapping Hexalobe Screw, 13mm
• 00844856068032: 4.5mm Fixed Angle, Self-Tapping Hexalobe Screw, 12mm
• 00844856068025: 4.5mm Fixed Angle, Self-Tapping Hexalobe Screw, 11mm
• 00844856068018: 4.5mm Fixed Angle, Self-Tapping Hexalobe Screw, 10mm
• 00844856068001: 4.0mm Fixed Angle, Self-Tapping Hexalobe Screw, 26mm
• 00844856067998: 4.0mm Fixed Angle, Self-Tapping Hexalobe Screw, 25mm
• 00844856067981: 4.0mm Fixed Angle, Self-Tapping Hexalobe Screw, 24mm
• 00844856067974: 4.0mm Fixed Angle, Self-Tapping Hexalobe Screw, 23mm
• 00844856067967: 4.0mm Fixed Angle, Self-Tapping Hexalobe Screw, 22mm
• 00844856067950: 4.0mm Fixed Angle, Self-Tapping Hexalobe Screw, 21mm
• 00844856067943: 4.0mm Fixed Angle, Self-Tapping, Hexalobe Screw, 20mm
• 00844856067936: 4.0mm Fixed Angle, Self-Tapping, Hexalobe Screw, 19mm
• 00844856067929: 4.0mm Fixed Angle, Self-Tapping, Hexalobe Screw, 18mm
• 00844856067912: 4.0mm Fixed Angle, Self-Tapping, Hexalobe Screw, 17mm
• 00844856067905: 4.0mm Fixed Angle, Self-Tapping, Hexalobe Screw, 16mm
• 00844856067899: 4.0mm Fixed Angle, Self-Tapping, Hexalobe Screw, 15mm
• 00844856067882: 4.0mm Fixed Angle, Self-Tapping, Hexalobe Screw, 14mm
• 00844856067875: 4.0mm Fixed Angle, Self-Tapping, Hexalobe Screw, 13mm
• 00844856067868: 4.0mm Fixed Angle, Self-Tapping, Hexalobe Screw, 12mm
• 00844856067851: 4.0mm Fixed Angle, Self-Tapping, Hexalobe Screw, 11mm
• 00844856067844: 4.0mm Fixed Angle, Self-Tapping, Hexalobe Screw, 10mm
• 00844856067837: 4.0mm Fixed Angle, Self-Drilling, Hexalobe Screw, 20mm
• 00844856067820: 4.0mm Fixed Angle, Self-Drilling, Hexalobe Screw, 19mm
• 00844856067813: 4.0mm Fixed Angle, Self-Drilling, Hexalobe Screw, 18mm
• 00844856067806: 4.0mm Fixed Angle, Self-Drilling, Hexalobe Screw, 17mm
• 00844856067790: 4.0mm Fixed Angle, Self-Drilling, Hexalobe Screw, 16mm
• 00844856067783: 4.0mm Fixed Angle, Self-Drilling, Hexalobe Screw, 15mm
• 00844856067776: 4.0mm Fixed Angle, Self-Drilling, Hexalobe Screw, 14mm
• 00844856067769: 4.0mm Fixed Angle, Self-Drilling, Hexalobe Screw, 13mm
• 00844856067752: 4.0mm Fixed Angle, Self-Drilling, Hexalobe Screw, 12mm
• 00844856067745: 4.0mm Fixed Angle, Self-Drilling, Hexalobe Screw, 11mm
• 00844856067738: 4.0mm Fixed Angle, Self-Drilling, Hexalobe Screw, 10mm
• 00844856067721: 4.5mm Variable Angle, Self-Tapping Hexalobe Screw, 26mm
• 00844856067714: 4.5mm Variable Angle, Self-Tapping Hexalobe Screw, 25mm
• 00844856067707: 4.5mm Variable Angle, Self-Tapping Hexalobe Screw, 24mm
• 00844856067691: 4.5mm Variable Angle, Self-Tapping Hexalobe Screw, 23mm
• 00844856067684: 4.5mm Variable Angle, Self-Tapping Hexalobe Screw, 22mm