Catalyft™ LS Expandable Interbody System

GUDID 00763000465889

SPACER 981025522 6MM ANT EXPANDABLE MD

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00763000465889
• NIH Device Record Key: 25d950de-86a0-4f23-85f6-c4bb6d0d9ea9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Catalyft™ LS Expandable Interbody System
• Version Model Number: 981025522
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000465889 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212653

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-10
• Device Publish Date: 2022-01-02

On-Brand Devices [Catalyft™ LS Expandable Interbody System]

• 00763000552435: SHAFT 981000007 ANTERIOR PARA/LORD 7N
• 00763000552428: SHAFT 981000006 ANTERIOR PARA/LORD 6N
• 00763000518363: TRAY 981990001 GENERAL INSTRUMENTS LOWER
• 00763000518356: TRAY 981990000 GENERAL INSTRUMENTS UPPER
• 00763000466084: SHAFT 981000003 ANTERIOR ANT/POST
• 00763000466077: SHAFT 981000002 ANTERIOR PARA/LORD
• 00763000466060: INSERTER 981000001 STRAIGHT INSERTER
• 00763000465995: SCREW 981315555 DIAMOND TIP 5.5X55MM
• 00763000465988: SCREW 981315550 DIAMOND TIP 5.5X50MM
• 00763000465971: SCREW 981315545 DIAMOND TIP 5.5X45MM
• 00763000465964: SCREW 981315540 DIAMOND TIP 5.5X40MM
• 00763000465957: SCREW 981315535 DIAMOND TIP 5.5X35MM
• 00763000465940: SCREW 981315530 DIAMOND TIP 5.5X30MM
• 00763000465933: SCREW 981315525 DIAMOND TIP 5.5X25MM
• 00763000465926: SCREW 981315520 DIAMOND TIP 5.5X20MM
• 00763000465919: SPACER 981027725 10MM ANT EXPANDABLE LG
• 00763000465902: SPACER 981027722 6MM ANT EXPANDABLE LG
• 00763000465896: SPACER 981025525 10MM ANT EXPANDABLE MD
• 00763000465889: SPACER 981025522 6MM ANT EXPANDABLE MD
• 00763000465872: SPACER 981023325 10MM ANT EXPANDABLE SM
• 00763000465865: SPACER 981023322 6MM ANT EXPANDABLE SM