VertebraLINK MI 84-0001

GUDID 00817329025672

VertebraLINK MI Set

LINKSPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00817329025672
• NIH Device Record Key: adb45246-7c47-4e27-89d2-efff363b91b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VertebraLINK MI
• Version Model Number: 84-0001
• Catalog Number: 84-0001
• Company DUNS: 067584601
• Company Name: LINKSPINE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 1-410-772-5465
• Email: cs@linkspine.com
• Phone: 1-410-772-5465
• Email: cs@linkspine.com
• Phone: 1-410-772-5465
• Email: cs@linkspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817329025672 [Primary]

FDA Product Code

• OJH: Orthopedic Tray

Sterilization

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

[00817329025672]

Moist Heat or Steam Sterilization

[00817329025672]

Moist Heat or Steam Sterilization

[00817329025672]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-07-06

On-Brand Devices [VertebraLINK MI]

• 00817329025672: VertebraLINK MI Set
• 00817329024590: MI Inserter - 10mm
• 00817329024583: MI Inserter - 8mm
• 00817329023203: MI Inserter Draw Rod
• 00817329023197: Bayonetted Scalpel Handle