VertebraLINK MI 84-0651-01

GUDID 00817329024583

MI Inserter - 8mm

LINKSPINE, INC.

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00817329024583
• NIH Device Record Key: 816349ee-a56c-4591-96e9-84f236e969c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VertebraLINK MI
• Version Model Number: 84-0651-01
• Catalog Number: 84-0651-01
• Company DUNS: 067584601
• Company Name: LINKSPINE, INC.
• 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: 1-410-772-5465
• 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	00817329024583 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162693

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00817329024583]

Moist Heat or Steam Sterilization

[00817329024583]

Moist Heat or Steam Sterilization

[00817329024583]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-05-29

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