Hexanium® TLIF

GUDID 03663136001531

Ti Straight TLIF Cage

SPINEVISION

Metallic spinal interbody fusion cage

• Primary Device ID: 03663136001531
• NIH Device Record Key: e8c255e7-2bb1-419e-8939-d6438b1e2619
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hexanium® TLIF
• Version Model Number: TL3-SCM15
• Company DUNS: 390377518
• Company Name: SPINEVISION
• 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: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com
• Phone: +33153332525
• Email: corp.quality@spinevision.com

Device Dimensions

• Height: 15 Millimeter
• Height: 15 Millimeter
• Height: 15 Millimeter
• Height: 15 Millimeter
• Height: 15 Millimeter
• Height: 15 Millimeter
• Height: 15 Millimeter
• Height: 15 Millimeter
• Height: 15 Millimeter
• Height: 15 Millimeter
• Height: 15 Millimeter
• Height: 15 Millimeter
• Height: 15 Millimeter
• Height: 15 Millimeter
• Height: 15 Millimeter
• Height: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03663136001531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210359

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-29
• Device Publish Date: 2021-03-19

On-Brand Devices [Hexanium® TLIF]

• 03663136033242: Ti TLIF Cage Small H16 mm
• 03663136033235: Ti TLIF Cage Small H15 mm
• 03663136033228: Ti TLIF Cage Small H14 mm
• 03663136033211: Ti TLIF Cage Small H13 mm
• 03663136033204: Ti TLIF Cage Small H12 mm
• 03663136033198: Ti TLIF Cage Small H11 mm
• 03663136033181: Ti TLIF Cage Small H10 mm
• 03663136033174: Ti TLIF Cage Small H09 mm
• 03663136033167: Ti TLIF Cage Small H08 mm
• 03663136033150: Ti TLIF Cage Small H07 mm
• 03663136033143: Ti TLIF Cage Medium H16 mm
• 03663136033136: Ti TLIF Cage Medium H15 mm
• 03663136033129: Ti TLIF Cage Medium H14 mm
• 03663136033112: Ti TLIF Cage Medium H13 mm
• 03663136033105: Ti TLIF Cage Medium H12 mm
• 03663136033099: Ti TLIF Cage Medium H11 mm
• 03663136033082: Ti TLIF Cage Medium H10 mm
• 03663136033075: Ti TLIF Cage Medium H09 mm
• 03663136033068: Ti TLIF Cage Medium H08 mm
• 03663136033051: Ti TLIF Cage Medium H07 mm
• 03663136032405: Ti TLIF Cage Trial Small 15
• 03663136032375: Ti TLIF Cage Trial Medium 16
• 03663136032368: Ti TLIF Cage Trial Medium 15
• 03663136032351: Ti TLIF Cage Trial Small 16
• 03663136032207: Ti TLIF Cage Trial Medium 14
• 03663136032191: Ti TLIF Cage Trial Medium 13
• 03663136032184: Ti TLIF Cage Trial Medium 12
• 03663136032177: Ti TLIF Cage Trial Medium 11
• 03663136032160: Ti TLIF Cage Trial Medium 10
• 03663136032153: Ti TLIF Cage Trial Medium 09
• 03663136032146: Ti TLIF Cage Trial Medium 08
• 03663136032139: Ti TLIF Cage Trial Medium 07
• 03663136032122: Ti TLIF Cage Trial Small 14
• 03663136032115: Ti TLIF Cage Trial Small 13
• 03663136032108: Ti TLIF Cage Trial Small 12
• 03663136032092: Ti TLIF Cage Trial Small 11
• 03663136032085: Ti TLIF Cage Trial Small 10
• 03663136032061: Ti TLIF Cage Trial Small 08
• 03663136032054: Ti TLIF Cage Trial Small 07
• 03663136001739: Ti Straight TLIF Cage Trial
• 03663136001722: Ti Straight TLIF Cage Trial
• 03663136001715: Ti Straight TLIF Cage
• 03663136001708: Ti Straight TLIF Cage
• 03663136001692: Ti Straight TLIF Cage
• 03663136001685: Ti Straight TLIF Cage
• 03663136001678: Ti Straight TLIF Cage
• 03663136001661: Ti Straight TLIF Cage
• 03663136001654: Ti Straight TLIF Cage
• 03663136001647: Ti Straight TLIF Cage
• 03663136001630: Ti Straight TLIF Cage