Hexanium® ACIF

GUDID 03663136000442

Convex Ti SA Cervical Cage

SPINEVISION

Metallic spinal interbody fusion cage

• Primary Device ID: 03663136000442
• NIH Device Record Key: db5507dd-d2a3-42ac-80e9-e27dc0299f22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hexanium® ACIF
• Version Model Number: AC2-CSS06C
• 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
• 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: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter
• Height: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03663136000442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193000

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

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: 2020-11-10
• Device Publish Date: 2020-11-02

On-Brand Devices [Hexanium® ACIF]

• 03663136000442: Convex Ti SA Cervical Cage
• 03663136000855: Ti Standard Cervical Tray
• 03663136000848: Ti SA Cervical Tray
• 03663136009186: Cylindrical Snap-On Torque Limiting Handle
• 03663136009179: Screwdriver Shaft
• 03663136000831: Lordotic Ti SA Cervical Cage
• 03663136000824: Lordotic Ti SA Cervical Cage
• 03663136000817: Lordotic Ti SA Cervical Cage
• 03663136000800: Lordotic Ti SA Cervical Cage
• 03663136000794: Lordotic Ti SA Cervical Cage
• 03663136000787: Lordotic Ti SA Cervical Cage
• 03663136000770: Lordotic Ti SA Cervical Cage
• 03663136000763: Lordotic Ti SA Cervical Cage
• 03663136000756: Lordotic Ti SA Cervical Cage
• 03663136000749: Lordotic Ti SA Cervical Cage
• 03663136000732: Lordotic Ti SA Cervical Cage
• 03663136000725: Lordotic Ti SA Cervical Cage
• 03663136000718: Lordotic Ti SA Cervical Cage
• 03663136000701: Lordotic Ti SA Cervical Cage
• 03663136000695: Lordotic Ti SA Cervical Cage
• 03663136000688: Lordotic Ti SA Cervical Cage
• 03663136000671: Lordotic Ti SA Cervical Cage
• 03663136000664: Lordotic Ti SA Cervical Cage
• 03663136000657: Lordotic Ti SA Cervical Cage
• 03663136000640: Lordotic Ti SA Cervical Cage
• 03663136000633: Lordotic Ti SA Cervical Cage
• 03663136000626: Lordotic Ti SA Cervical Cage
• 03663136000619: Lordotic Ti SA Cervical Cage
• 03663136000602: Lordotic Ti SA Cervical Cage
• 03663136000596: Self-Drilling Screws
• 03663136000589: Self-Drilling Screws
• 03663136000572: Self-Drilling Screws
• 03663136000565: Self-Drilling Screws
• 03663136000558: Self-Drilling Screws
• 03663136000541: Self-Drilling Screws
• 03663136000534: Self-Drilling Screws
• 03663136000527: Self-Drilling Screws
• 03663136000459: Convex Ti SA Cervical Cage
• 03663136000435: Convex Ti SA Cervical Cage
• 03663136000428: Convex Ti SA Cervical Cage
• 03663136000411: Convex Ti SA Cervical Cage
• 03663136000404: Convex Ti SA Cervical Cage
• 03663136000398: Convex Ti SA Cervical Cage
• 03663136000381: Convex Ti SA Cervical Cage
• 03663136000374: Convex Ti SA Cervical Cage
• 03663136000367: Convex Ti SA Cervical Cage
• 03663136000350: Convex Ti SA Cervical Cage
• 03663136000343: Convex Ti SA Cervical Cage
• 03663136000336: Convex Ti SA Cervical Cage
• 03663136000329: Convex Ti SA Cervical Cage