ZPLATE II™ Anterior Fixation System

GUDID 00673978948379

SCREW 822-235 ANT LWPRFL 6.5X35MM

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00673978948379
• NIH Device Record Key: 53b06e26-4b79-4319-a3a5-7e5e63dd279a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZPLATE II™ Anterior Fixation System
• Version Model Number: 822-235
• 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: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673978948379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922543

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00673978948379]

Moist Heat or Steam Sterilization

[00673978948379]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-19

On-Brand Devices [ZPLATE II™ Anterior Fixation System]

• 00673978948379: SCREW 822-235 ANT LWPRFL 6.5X35MM
• 00673978928449: SCREW 822-230 ANT LWPRFL 6.5X30MM