Pathway

GUDID 00840916113025

Pathway ACIF 9mm, 0 degrees

SPINAL ELEMENTS

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840916113025
• NIH Device Record Key: 51c35e8e-3a1f-4361-95af-9d2b07e0eec3
• Commercial Distribution Discontinuation: 2020-03-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Pathway
• Version Model Number: 100900
• Company DUNS: 004022104
• Company Name: SPINAL ELEMENTS
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840916113025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092904

FDA Product Code

• MQP: Spinal Vertebral Body Replacement Device

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840916113025]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-03-20
• Device Publish Date: 2017-07-31

On-Brand Devices [Pathway]

• 00840916129644: Pathway ELIF Large 12mm
• 00840916129637: Pathway ELIF Large 11mm
• 00840916129620: Pathway ELIF Large 10mm
• 00840916129613: Pathway ELIF Large 9mm
• 00840916129606: Pathway ELIF Large 8mm
• 00840916129590: Pathway ELIF Large 7mm
• 00840916129583: Pathway ELIF Small 12mm
• 00840916129576: Pathway ELIF Small 11mm
• 00840916129569: Pathway ELIF Small 10mm
• 00840916129552: Pathway ELIF Small 9mm
• 00840916129545: Pathway ELIF Small 8mm
• 00840916129538: Pathway ELIF Small 7mm
• 00840916113445: TLIF 10mm W, 14mm
• 00840916113438: TLIF 10mm W, 13mm
• 00840916113421: TLIF 10mm W, 12mm
• 00840916113414: TLIF 10mm W, 11mm
• 00840916113407: TLIF 10mm W, 10mm
• 00840916113391: TLIF 10mm W, 9mm
• 00840916113384: TLIF 10mm W, 8mm
• 00840916113377: TLIF 10mm W, 7mm
• 00840916113360: PLIF 8mm W, 14mm, 6 degrees
• 00840916113353: PLIF 8mm W, 13mm, 6 degrees
• 00840916113346: PLIF 8mm W, 12mm, 6 degrees
• 00840916113339: PLIF 8mm W, 11mm, 6 degrees
• 00840916113322: PLIF 8mm W, 10mm, 6 degrees
• 00840916113315: PLIF 8mm W, 9mm, 6 degrees
• 00840916113308: PLIF 8mm W, 8mm, 6 degrees
• 00840916113292: PLIF 8mm W, 7mm, 6 degrees
• 00840916113285: PLIF 10mm W, 14mm, 0 degrees
• 00840916113278: PLIF 10mm W, 13mm, 0 degrees
• 00840916113261: PLIF 10mm W, 12mm, 0 degrees
• 00840916113254: PLIF 10mm W, 11mm, 0 degrees
• 00840916113247: PLIF 10mm W, 10mm, 0 degrees
• 00840916113230: PLIF 10mm W, 9mm, 0 degrees
• 00840916113223: PLIF 10mm W, 8mm, 0 degrees
• 00840916113216: PLIF 10mm W, 7mm, 0 degrees
• 00840916113094: Pathway ACIF 12mm, 7 degrees
• 00840916113087: Pathway ACIF 12mm, 0 degrees
• 00840916113070: Pathway ACIF 11mm, 7 degrees
• 00840916113063: Pathway ACIF 11mm, 0 degrees
• 00840916113056: Pathway ACIF 10mm, 7 degrees
• 00840916113049: Pathway ACIF 10mm, 0 degrees
• 00840916113032: Pathway ACIF 9mm, 7 degrees
• 00840916113025: Pathway ACIF 9mm, 0 degrees
• 00840916113018: Pathway ACIF 8mm, 7 degrees
• 00840916113001: Pathway ACIF 8mm, 0 degrees
• 00840916112998: Pathway ACIF 7mm, 7 degrees
• 00840916112981: Pathway ACIF 7mm, 0 degrees
• 00840916112974: Pathway ACIF 6mm, 7 degrees
• 00840916112967: Pathway ACIF 6mm, 0 degrees