PYRAMID® Anterior Plate Fixation System

GUDID 00721902214394

PLATE 8969119 PLATE 19MM

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal fusion cage, non-sterile Metallic spinal fusion cage, non-sterile Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 00721902214394
• NIH Device Record Key: 0f0a9375-3c20-4b26-b8ff-58b664feede4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PYRAMID® Anterior Plate Fixation System
• Version Model Number: 8969119
• 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
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902214394 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013665

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00721902214394]

Moist Heat or Steam Sterilization

[00721902214394]

Moist Heat or Steam Sterilization

[00721902214394]

Moist Heat or Steam Sterilization

[00721902214394]

Moist Heat or Steam Sterilization

[00721902214394]

Moist Heat or Steam Sterilization

[00721902214394]

Moist Heat or Steam Sterilization

[00721902214394]

Moist Heat or Steam Sterilization

[00721902214394]

Moist Heat or Steam Sterilization

[00721902214394]

Moist Heat or Steam Sterilization

[00721902214394]

Moist Heat or Steam Sterilization

[00721902214394]

Moist Heat or Steam Sterilization

[00721902214394]

Moist Heat or Steam Sterilization

[00721902214394]

Moist Heat or Steam Sterilization

[00721902214394]

Moist Heat or Steam Sterilization

[00721902214394]

Moist Heat or Steam Sterilization

[00721902214394]

Moist Heat or Steam Sterilization

[00721902214394]

Moist Heat or Steam Sterilization

[00721902214394]

Moist Heat or Steam Sterilization

[00721902214394]

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: 2015-07-30

On-Brand Devices [PYRAMID® Anterior Plate Fixation System]

• 00613994116819: SCREW X1105414 BONE SCREW 6.5X50MM TI
• 00613994116802: SCREW X1105413 BONE SCREW 6.5X45MM TI
• 00613994116796: SCREW X1105412 BONE SCREW 6.5X40MM TI
• 00613994116789: SCREW X1105411 BONE SCREW 6.5X35MM TI
• 00613994116772: SCREW X1105410 BONE SCREW 6.5X30MM TI
• 00613994116765: SCREW X1105409 BONE SCREW 6.5X25MM TI
• 00721902937057: 6.5X55 TAPERED BONE SCREW
• 00721902937040: 6.5X50 TAPERED BONE SCREW
• 00721902337666: SCREW 8968645 XANTUS BONE FAS 6.5X45MM
• 00721902337659: SCREW 8968640 XANTUS BONE FAS 6.5X40MM
• 00721902337635: SCREW 8968635 PYRMD BONE FAS 6.5X35MM
• 00721902337628: SCREW 8968630 PYRMD BONE FAS 6.5X30MM
• 00721902337611: SCREW 8968625 PYRMD BONE FAS 6.5X25MM
• 00721902214547: PLATE 8969227 COVER PLATE 27MM
• 00721902214523: PLATE 8969225 COVER PLATE 25MM
• 00721902214516: PLATE 8969223 COVER PLATE 23MM
• 00721902214493: PLATE 8969221 COVER PLATE 21MM
• 00721902214486: PLATE 8969219 COVER PLATE 19MM
• 00721902214479: PLATE 8969217 COVER PLATE 17MM
• 00721902214455: PLATE 8969127 PLATE 27MM
• 00721902214448: PLATE 8969125 PLATE 25MM
• 00721902214431: PLATE 8969123 PLATE 23MM
• 00721902214417: PLATE 8969121 PLATE 21MM
• 00721902214394: PLATE 8969119 PLATE 19MM
• 00721902214363: PLATE 8969117 PLATE 17MM