PERIMETER® Interbody Fusion Device 

GUDID 00643169167513

SPACER X1111491 PERIMETER LG 8DEG 13MM

MEDTRONIC SOFAMOR DANEK, INC.

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: 00643169167513
• NIH Device Record Key: 94dbcd4f-9043-4107-ac18-b47b9b054179
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERIMETER® Interbody Fusion Device
• Version Model Number: X1111491
• 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

Device Dimensions

• Width: 30 Millimeter
• Width: 30 Millimeter
• Width: 30 Millimeter
• Width: 30 Millimeter
• Width: 30 Millimeter
• Width: 30 Millimeter
• Width: 30 Millimeter
• Width: 30 Millimeter
• Length: 24 Millimeter
• Height: 13 Millimeter
• Angle: 8 degree
• Width: 30 Millimeter
• Length: 24 Millimeter
• Height: 13 Millimeter
• Angle: 8 degree
• Width: 30 Millimeter
• Length: 24 Millimeter
• Height: 13 Millimeter
• Angle: 8 degree
• Width: 30 Millimeter
• Length: 24 Millimeter
• Height: 13 Millimeter
• Angle: 8 degree
• Width: 30 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169167513 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090353

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-06-25

On-Brand Devices [PERIMETER® Interbody Fusion Device ]

• 00643169167650: SPACER X1111477 PERIMETER SM 4DEG 9MM
• 00643169167599: SPACER X1111499 PERIMETER LG 12DEG 19MM
• 00643169167582: SPACER X1111498 PERIMETER LG 12DEG 17MM
• 00643169167575: SPACER X1111497 PERIMETER LG 12DEG 15MM
• 00643169167568: SPACER X1111496 PERIMETER LG 12DEG 13MM
• 00643169167551: SPACER X1111495 PERIMETER LG 12DEG 11MM
• 00643169167544: SPACER X1111494 PERIMETER LG 8DEG 19MM
• 00643169167537: SPACER X1111493 PERIMETER LG 8DEG 17MM
• 00643169167520: SPACER X1111492 PERIMETER LG 8DEG 15MM
• 00643169167513: SPACER X1111491 PERIMETER LG 8DEG 13MM