INTER FIX™ RP Threaded Fusion Device

GUDID 00673978957531

22X23 INTERFIXRP FUSION DEVICE

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00673978957531
• NIH Device Record Key: 82b598fa-9efa-4692-b82d-e216a421cb21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTER FIX™ RP Threaded Fusion Device
• Version Model Number: 9012223
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Outer Diameter: 22 Millimeter
• Outer Diameter: 22 Millimeter
• Outer Diameter: 22 Millimeter
• Outer Diameter: 22 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673978957531 [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: 2014-09-23

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

• 00673978957593: 24X29 INTERFIXRP FUSION DEVICE
• 00673978957586: 24X26 INTERFIXRP FUSION DEVICE
• 00673978957579: 24X23 INTERFIXRP FUSION DEVICE
• 00673978957562: 24X20 INTERFIXRP FUSION DEVICE
• 00673978957555: 22X29 INTERFIXRP FUSION DEVICE
• 00673978957548: 22X26 INTERFIXRP FUSION DEVICE
• 00673978957531: 22X23 INTERFIXRP FUSION DEVICE
• 00673978957524: 22X20 INTERFIXRP FUSION DEVICE
• 00673978957517: 20X29 INTERFIXRP FUSION DEVICE
• 00673978957500: 20X26 INTERFIXRP FUSION DEVICE
• 00673978957494: 20X23 INTERFIXRP FUSION DEVICE
• 00673978957487: 20X20 INTERFIXRP FUSION DEVICE
• 00673978957470: 18X29 INTERFIXRP FUSION DEVICE
• 00673978957463: 18X26 INTERFIXRP FUSION DEVICE
• 00673978957456: 18X23 INTERFIXRP FUSION DEVICE
• 00673978957449: 18X20 INTERFIXRP FUSION DEVICE
• 00673978957432: 16X29 INTERFIXRP FUSION DEVICE
• 00673978957425: 16X26 INTERFIXRP FUSION DEVICE
• 00673978957418: 16X23 INTERFIXRP FUSION DEVICE
• 00673978957401: 16X20 INTERFIXRP FUSION DEVICE
• 00673978957395: 14X29 INTERFIXRP FUSION DEVICE
• 00673978957388: 14X26 INTERFIXRP FUSION DEVICE
• 00673978957371: 14X23 INTERFIXRP FUSION DEVICE
• 00673978957364: 14X20 INTERFIXRP FUSION DEVICE
• 00673978957357: 12X25 INTERFIXRP FUSION DEVICE
• 00673978957340: 12X20 INTERFIXRP FUSION DEVICE