VertebraLINK 84-0003/0906

GUDID 00817329021087

8 x 26 x 9 x 6 PLIF IBD

LINKSPINE, INC.

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00817329021087
• NIH Device Record Key: c1b5325f-0dc0-43d9-8a81-974e98d0f96e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VertebraLINK
• Version Model Number: 84-0003/0906
• Catalog Number: 84-0003/0906
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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 Dimensions

• Angle: 6 degree
• Angle: 6 degree
• Angle: 6 degree
• Angle: 6 degree
• Angle: 6 degree
• Angle: 6 degree
• Angle: 6 degree
• Angle: 6 degree
• Angle: 6 degree
• Angle: 6 degree
• Angle: 6 degree
• Angle: 6 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817329021087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162693

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-11-28
• Device Publish Date: 2017-05-18

On-Brand Devices [VertebraLINK]

• 00817329025894: 8 x 26 x 6 x 6 PLIF IBD
• 00817329025887: 300mm Lordotic Trial 13mm
• 00817329025870: 300mm Lordotic Trial 12mm
• 00817329025863: 300mm Lordotic Trial 11mm
• 00817329025856: 300mm Lordotic Trial 10mm
• 00817329025849: 300mm Lordotic Trial 9mm
• 00817329025832: 300mm Lordotic Trial 8mm
• 00817329025825: 300mm Lordotic Trial 7mm
• 00817329025665: VertebraLINK Set
• 00817329025603: 300mm Trials
• 00817329025597: 300mm Trials
• 00817329025580: 300mm Trials
• 00817329025573: 300mm Trials
• 00817329025566: 300mm Trials
• 00817329025559: 300mm Trials
• 00817329025542: 300mm Trials
• 00817329025535: 300mm Trials
• 00817329025528: 300mm Spreader Shavers
• 00817329025511: 300mm Spreader Shavers
• 00817329025504: 300mm Spreader Shavers
• 00817329025498: 300mm Spreader Shavers
• 00817329025481: 300mm Spreader Shavers
• 00817329025474: 300mm Spreader Shavers
• 00817329025467: 300mm Spreader Shavers
• 00817329025450: 300mm Spreader Shavers
• 00817329025443: 300mm Pituitaries
• 00817329025436: 300mm Pituitaries
• 00817329025429: 300mm Pituitaries
• 00817329025412: 300mm Pituitaries
• 00817329025405: 300mm Pituitaries
• 00817329025399: 300mm Pituitaries
• 00817329025382: 300mm Curette
• 00817329025375: 300mm Curette
• 00817329025368: 300mm Curette
• 00817329025351: 300mm Curette
• 00817329025344: 300mm Curette
• 00817329025337: 300mm Curette
• 00817329025320: VertebraLINK Disc Prep Tray 3
• 00817329025313: VertebraLINK Posterior Disc Prep Tray 2
• 00817329025306: VertebraLINK Posterior Disc Prep Tray 1
• 00817329025290: VertebraLINK Insertion Tray
• 00817329025283: VertebraLINK Prep Tray 1
• 00817329025276: 300mm Kerrisons
• 00817329025269: 300mm Kerrisons
• 00817329025252: Angled Ring Curette 300mm
• 00817329025245: Angled Ring Curette 300mm
• 00817329025238: 300mm Angled Ring Curette
• 00817329025221: 300mm Angled Ring Curette
• 00817329025214: 300mm Ring Curette
• 00817329025207: Ring Curette 300mm