Perimeter Interbody Fusion Device

GUDID 00613994915801

SPACER X0910130 PER TI XL 12D 36X14

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00613994915801
• NIH Device Record Key: 8d7e9a00-7572-4df1-8f2d-7cd95d5242f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perimeter Interbody Fusion Device
• Version Model Number: X0910130
• 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

Device Dimensions

• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter
• Height: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994915801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111525

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00613994915801]

Moist Heat or Steam Sterilization

[00613994915801]

Moist Heat or Steam Sterilization

[00613994915801]

Moist Heat or Steam Sterilization

[00613994915801]

Moist Heat or Steam Sterilization

[00613994915801]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-09

On-Brand Devices [Perimeter Interbody Fusion Device]

• 00613994915863: SPACER X0910124 PER TI XL 8D 36X16
• 00613994915856: SPACER X0910125 PER TI XL 8D 36X18
• 00613994915849: SPACER X0910126 PER TI XL 8D 36X20
• 00613994915832: SPACER X0910127 PER TI XL 12D 36X8
• 00613994915825: SPACER X0910128 PER TI XL 12D 36X10
• 00613994915818: SPACER X0910129 PER TI XL 12D 36X12
• 00613994915801: SPACER X0910130 PER TI XL 12D 36X14
• 00613994915795: SPACER X0910131 PER TI XL 12D 36X16
• 00613994915788: SPACER X0910132 PER TI XL 12D 36X18
• 00613994915771: SPACER X0910133 PER TI XL 12D 36X20
• 00613994915764: SPACER X1110068 PER TI XXL 8D 38X8
• 00613994915757: SPACER X1110069 PER TI XXL 8D 38X10
• 00613994915740: SPACER X1110070 PER TI XXL 8D 38X12
• 00613994915733: SPACER X1110071 PER TI XXL 8D 38X14