INTER FIX™ Threaded Fusion Device

GUDID 00673978071985

12X25MM INTER FIX LC W/END CAP

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00673978071985
• NIH Device Record Key: eb24c1e9-4fc1-4883-b96d-2431c1d5c448
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTER FIX™ Threaded Fusion Device
• Version Model Number: 890-125
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, 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: 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673978071985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000058

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: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2014-12-17

On-Brand Devices [INTER FIX™ Threaded Fusion Device]

• 00681490499699: 24X20MM INTER FIX THREADED
• 00681490499682: 22X20MM INTER FIX THREADED
• 00673978955827: 24X29MM INTER FIX THREADED
• 00673978955810: 24X26MM INTER FIX THREADED
• 00673978955803: 24X23MM INTER FIX THREADED
• 00673978955780: 22X29MM INTER FIX THREADED
• 00673978955773: 22X26MM INTER FIX THREADED
• 00673978955766: 22X23MM INTER FIX THREADED
• 00673978072319: 20X29MM INTER FIX THREADED
• 00673978072289: 20X26MM INTER FIX THREADED
• 00673978072265: 20X23MM INTER FIX THREADED
• 00673978072241: 20X20MM INTER FIX THREADED
• 00673978072227: 18X29MM INTER FIX THREADED
• 00673978072203: 18X26MM INTER FIX THREADED
• 00673978072180: 18X23MM INTER FIX THREADED
• 00673978072166: 18X20MM INTER FIX THREADED
• 00673978072142: 16X29MM INTER FIX THREADED
• 00673978072128: 16X26MM INTER FIX THREADED
• 00673978072104: 16X23MM INTER FIX THREADED
• 00673978072081: 16X20MM INTER FIX THREADED
• 00673978072067: 14X29MM INTER FIX LC W/END CAP
• 00673978072043: CAGE 890-146 14X26MM INTER FIX THREADED
• 00673978072029: 14X23MM INTER FIX THREADED
• 00673978072005: 14X20MM INTER FIX THREADED
• 00673978071985: 12X25MM INTER FIX LC W/END CAP
• 00673978071961: 12X20MM INTER FIX LC W/END CAP