GRAFTON PLUS™ DBM

GUDID 00643169965102

DBM T45005INT 5CC PASTE GRAFTON PLUS

MEDTRONIC SOFAMOR DANEK, INC.

Bone matrix implant, human-derived
Primary Device ID00643169965102
NIH Device Record Key071d4e91-b5cb-4b47-a046-2378f660ef21
Commercial Distribution StatusIn Commercial Distribution
Brand NameGRAFTON PLUS™ DBM
Version Model NumberT45005INT
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Producttrue
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169965102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBPFiller, bone void, osteoinduction (w/o human growth factor)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-25
Device Publish Date2024-11-15

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

00763000857431 - VERTE-STACK® Spinal System2025-03-14 SPACER 6286511 PSR LAT PORTS 5X11X11
00763000864637 - n/a2025-03-14 TOOL 4360002 END CAP REMOVAL TOOL
00763000864644 - n/a2025-03-14 TOOL 4360320 IMPLANT REMOVAL TOOL
00763000864668 - T2™ Spinal System2025-03-14 DRIVER 4360520 T17 DRIVER
00763000862909 - General Instruments2025-03-11 DRIVER X981000033 RETAINING STRAIGHT T25
00763000862916 - General Instruments2025-03-11 AWL X981000035 AWL ANGLED
00763000862930 - General Instruments2025-03-11 DRIVER X981000036 RETAINING 40 DEG T25
00763000862947 - General Instruments2025-03-11 DRIVER X981000136 40DEG T25 DRIVER

Trademark Results [GRAFTON PLUS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GRAFTON PLUS
GRAFTON PLUS
76344860 2707900 Live/Registered
Osteotech, Inc.
2001-12-04

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