CHOICE SPINE LUMBAR SPACER SYSTEM

GUDID 00840996170628

LUMBAR,CURETTE,CUP,STRAIGHT,LEFT,#2

Choice Spine, LP

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840996170628
• NIH Device Record Key: 5fb7ebfb-2c3d-454a-bccc-fd48d5a1ae21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHOICE SPINE LUMBAR SPACER SYSTEM
• Version Model Number: P070-CUP01
• Company DUNS: 078293017
• Company Name: Choice Spine, LP
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996170628 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162103

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00840996170628]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-24
• Device Publish Date: 2018-03-22

On-Brand Devices [CHOICE SPINE LUMBAR SPACER SYSTEM]

• 00840996170666: LUMBAR,CURETTE,CUP,69 DEG,PULL,#2
• 00840996170659: LUMBAR,CURETTE,CUP,ANGLE,RIGHT,#2
• 00840996170642: LUMBAR,CURETTE,CUP,ANGLE,LEFT,#2
• 00840996170635: LUMBAR,CURETTE,CUP,STRAIGHT,RIGHT,#2
• 00840996170628: LUMBAR,CURETTE,CUP,STRAIGHT,LEFT,#2