PYRAMID® Anterior Plate Fixation System

GUDID 00721902214493

PLATE 8969221 COVER PLATE 21MM

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal fusion cage, non-sterile

• Primary Device ID: 00721902214493
• NIH Device Record Key: 402ef2a0-c554-41cc-a4e6-42b0cb892b02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PYRAMID® Anterior Plate Fixation System
• Version Model Number: 8969221
• 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	00721902214493 [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

[00721902214493]

Moist Heat or Steam Sterilization

[00721902214493]

Moist Heat or Steam Sterilization

[00721902214493]

Moist Heat or Steam Sterilization

[00721902214493]

Moist Heat or Steam Sterilization

[00721902214493]

Moist Heat or Steam Sterilization

[00721902214493]

Moist Heat or Steam Sterilization

[00721902214493]

Moist Heat or Steam Sterilization

[00721902214493]

Moist Heat or Steam Sterilization

[00721902214493]

Moist Heat or Steam Sterilization

[00721902214493]

Moist Heat or Steam Sterilization

[00721902214493]

Moist Heat or Steam Sterilization

[00721902214493]

Moist Heat or Steam Sterilization

[00721902214493]

Moist Heat or Steam Sterilization

[00721902214493]

Moist Heat or Steam Sterilization

[00721902214493]

Moist Heat or Steam Sterilization

[00721902214493]

Moist Heat or Steam Sterilization

[00721902214493]

Moist Heat or Steam Sterilization

[00721902214493]

Moist Heat or Steam Sterilization

[00721902214493]

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