PERIMETER® Interbody Fusion Device 

GUDID 00643169167544

SPACER X1111494 PERIMETER LG 8DEG 19MM

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00643169167544
• NIH Device Record Key: 0172c4c8-23c3-410b-b4dd-32c6e7ea0237
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERIMETER® Interbody Fusion Device
• Version Model Number: X1111494
• 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

Device Dimensions

• Angle: 8 degree
• Angle: 8 degree
• Angle: 8 degree
• Angle: 8 degree
• Angle: 8 degree
• Angle: 8 degree
• Angle: 8 degree
• Angle: 8 degree
• Height: 19 Millimeter
• Length: 24 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 19 Millimeter
• Length: 24 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 19 Millimeter
• Length: 24 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree
• Height: 19 Millimeter
• Length: 24 Millimeter
• Width: 30 Millimeter
• Angle: 8 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169167544 [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