GRAFTON PLUS™ DBM

GUDID 00643169965102

DBM T45005INT 5CC PASTE GRAFTON PLUS

MEDTRONIC SOFAMOR DANEK, INC.

Bone matrix implant, human-derived

• Primary Device ID: 00643169965102
• NIH Device Record Key: 071d4e91-b5cb-4b47-a046-2378f660ef21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GRAFTON PLUS™ DBM
• Version Model Number: T45005INT
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: true
• 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
• 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	00643169965102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042707
• Premarket Notification: K043048

FDA Product Code

• MBP: Filler, bone void, osteoinduction (w/o human growth factor)

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: 2024-11-25
• Device Publish Date: 2024-11-15

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00763000857349 - VERTE-STACK® Spinal System: 2025-01-07 SPACER 6272044 PSR STRUT 44 X 14 X 11MM
• 00763000857493 - VERTE-STACK® Spinal System: 2025-01-07 SPACER 6287141 PSR LAT PORTS 11X14X11
• 00763000857530 - VERTE-STACK® Spinal System: 2025-01-07 SPACER 6287641 PSR LAT PORTS 6X14X11
• 00763000650254 - CD Horizon™ ModuLeX™ FNS Screw Set: 2025-01-06 SHANK 55900524530 CANN OG FNS 4.5X30 TI
• 00763000650261 - CD Horizon™ ModuLeX™ FNS Screw Set: 2025-01-06 SHANK 55900524535 CANN OG FNS 4.5X35 TI
• 00763000650278 - CD Horizon™ ModuLeX™ FNS Screw Set: 2025-01-06 SHANK 55900524540 CANN OG FNS 4.5X40 TI
• 00763000650285 - CD Horizon™ ModuLeX™ FNS Screw Set: 2025-01-06 SHANK 55900524545 CANN OG FNS 4.5X45 TI
• 00763000650292 - CD Horizon™ ModuLeX™ FNS Screw Set: 2025-01-06 SHANK 55900524550 CANN OG FNS 4.5X50 TI