Gibralt Spine System

GUDID 00840996169882

GIBRALT,TAP,NO SLEEVE,4.5

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996169882
• NIH Device Record Key: bfedb8d4-8bb6-4435-872d-aeff574d1b1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gibralt Spine System
• Version Model Number: 05-009-98-0045
• Company DUNS: 078293017
• Company Name: Choice Spine, LP
• 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(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996169882 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110197

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00840996169882]

Moist Heat or Steam Sterilization

[00840996169882]

Moist Heat or Steam Sterilization

[00840996169882]

Moist Heat or Steam Sterilization

[00840996169882]

Moist Heat or Steam Sterilization

[00840996169882]

Moist Heat or Steam Sterilization

[00840996169882]

Moist Heat or Steam Sterilization

[00840996169882]

Moist Heat or Steam Sterilization

[00840996169882]

Moist Heat or Steam Sterilization

[00840996169882]

Moist Heat or Steam Sterilization

[00840996169882]

Moist Heat or Steam Sterilization

[00840996169882]

Moist Heat or Steam Sterilization

[00840996169882]

Moist Heat or Steam Sterilization

[00840996169882]

Moist Heat or Steam Sterilization

[00840996169882]

Moist Heat or Steam Sterilization

[00840996169882]

Moist Heat or Steam Sterilization

[00840996169882]

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: 2018-02-17

On-Brand Devices [Gibralt Spine System]

• 00840996169912: GIBRALT,TAP,4.5
• 00840996169905: GIBRALT,TAP,4.0
• 00840996169899: GIBRALT,TAP,3.5
• 00840996169882: GIBRALT,TAP,NO SLEEVE,4.5
• 00840996169875: GIBRALT,TAP,NO SLEEVE,4.0
• 00840996169868: GIBRALT,TAP,NO SLEEVE,3.5
• 00840996169851: GIBRALT,TAP,NO SLEEVE,3.0
• 00840996169844: GIBRALT,DRILL,ADUSTABLE,2.4
• 00840996166119: GIBRALT,DRILL,ADUSTABLE,2.0
• 00840996160674: GIBRALT, CONNECTOR, CAP
• 00840996150323: GIBRALT,SET SCREW,DRIVER,RETAINING SHAFT