Hexanium® ACIF

GUDID 03663136000541

Self-Drilling Screws

SPINEVISION

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 03663136000541
• NIH Device Record Key: 487c02f6-03b4-4cea-87a2-bfe10b8c609b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hexanium® ACIF
• Version Model Number: AC2-SD3812S
• 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

Device Dimensions

• Length: 12 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03663136000541 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-10-26
• Device Publish Date: 2020-11-09

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