XIPHOS ZFUZE ZF-100-2212

GUDID 00853896008045

PLIF Spacer 22mm Long x 12mm Height

Difusion Technologies, Inc.

Interspinous spinal fixation implant

• Primary Device ID: 00853896008045
• NIH Device Record Key: d413590f-bf50-4672-bb88-3957a129044e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XIPHOS ZFUZE
• Version Model Number: ZF-100-2212
• Catalog Number: ZF-100-2212
• Company DUNS: 022051967
• Company Name: Difusion Technologies, 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: true
• 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: 512-284-4440
• Email: customerservice@difusiontech.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853896008045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190544

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-02
• Device Publish Date: 2020-02-21

On-Brand Devices [XIPHOS ZFUZE]

• 00853896008182: PLIF Spacer 29mm Long x 12mm Height
• 00853896008410: TLIF Spacer 30mm Long x 8mm Height
• 00853896008403: TLIF Spacer 27mm Long x 11mm Height
• 00853896008397: TLIF Spacer 27mm Long x 14mm Height
• 00853896008380: TLIF Spacer 27mm Long x 13mm Height
• 00853896008373: TLIF Spacer 27mm Long x 12mm Height
• 00853896008366: TLIF Spacer 27mm Long x 10mm Height
• 00853896008359: TLIF Spacer 30mm Long x 14mm Height
• 00853896008342: TLIF Spacer 30mm Long x 13mm Height
• 00853896008335: TLIF Spacer 30mm Long x 12mm Height
• 00853896008311: TLIF Spacer 30mm Long x 10mm Height
• 00853896008304: TLIF Spacer 30mm Long x 9mm Height
• 00853896008298: TLIF Spacer 27mm Long x 9mm Height
• 00853896008281: TLIF Spacer 27mm Long x 8mm Height
• 00853896008274: TLIF Spacer 24mm Long x 14mm Height
• 00853896008267: TLIF Spacer 24mm Long x 13mm Height
• 00853896008250: TLIF Spacer 24mm Long x 12mm Height
• 00853896008243: TLIF Spacer 24mm Long x 11mm Height
• 00853896008236: TLIF Spacer 24mm Long x 10mm Height
• 00853896008229: TLIF Spacer 24mm Long x 9mm Height
• 00853896008212: TLIF Spacer 24mm Long x 8mm Height
• 00853896008205: PLIF Spacer 29mm Long x 14mm Height
• 00853896008199: PLIF Spacer 29mm Long x 13mm Height
• 00853896008175: PLIF Spacer 29mm Long x 11mm Height
• 00853896008168: PLIF Spacer 29mm Long x 10mm Height
• 00853896008151: PLIF Spacer 29mm Long x 9mm Height
• 00853896008144: PLIF Spacer 29mm Long x 8mm Height
• 00853896008137: PLIF Spacer 26mm Long x 14mm Height
• 00853896008120: PLIF Spacer 26mm Long x 13mm Height
• 00853896008113: PLIF Spacer 26mm Long x 12mm Height
• 00853896008106: PLIF Spacer 26mm Long x 11mm Height
• 00853896008090: PLIF Spacer 26mm Long x 10mm Height
• 00853896008083: PLIF Spacer 26mm Long x 9mm Height
• 00853896008076: PLIF Spacer 26mm Long x 8mm Height
• 00853896008069: PLIF Spacer 22mm Long x 14mm Height
• 00853896008052: PLIF Spacer 22mm Long x 13mm Height
• 00853896008045: PLIF Spacer 22mm Long x 12mm Height
• 00853896008038: PLIF Spacer 22mm Long x 10mm Height
• 00853896008021: PLIF Spacer 22mm Long x 9mm Height
• 00853896008014: PLIF Spacer 22mm Long x 8mm Height
• 00853896008007: PLIF Spacer 22mm Long x 11mm Height