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.

• 00763000857431 - VERTE-STACK® Spinal System: 2025-03-14 SPACER 6286511 PSR LAT PORTS 5X11X11
• 00763000864637 - n/a: 2025-03-14 TOOL 4360002 END CAP REMOVAL TOOL
• 00763000864644 - n/a: 2025-03-14 TOOL 4360320 IMPLANT REMOVAL TOOL
• 00763000864668 - T2™ Spinal System: 2025-03-14 DRIVER 4360520 T17 DRIVER
• 00763000862909 - General Instruments: 2025-03-11 DRIVER X981000033 RETAINING STRAIGHT T25
• 00763000862916 - General Instruments: 2025-03-11 AWL X981000035 AWL ANGLED
• 00763000862930 - General Instruments: 2025-03-11 DRIVER X981000036 RETAINING 40 DEG T25
• 00763000862947 - General Instruments: 2025-03-11 DRIVER X981000136 40DEG T25 DRIVER