FDA.reportPublic FDA data

GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)

Primary DI
00643169123021
Brand
GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
T45005
Device description
DBM T45005 5CC PASTE GRAFTON PLUS
Published
2015-07-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBPFiller, bone void, osteoinduction (w/o human growth factor)
NUNBONE GRAFTING MATERIAL, HUMAN SOURCE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)Orthopedic2
NUNBone Grafting Material, Human SourceDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042707000
K043048000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042707000GRAFTON PLUS DBM PASTEOsteotech, Inc.2005-11-30NUN
K043048000GRAFTON PLUS DBM PASTEOsteotech, Inc.2005-11-23MBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169123021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169123021006431691230216431691230210643169123021

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, human-derivedAn sterile implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. The device is bioabsorbable, osteoconductive, and has demonstrated at least potential osteoinductivity for the stimulation of new bone growth. The DBM may be combined with various carrier compounds (e.g., gelatin, hydrogel, starch) or other materials. It is available in the form of powder, crushed granules, putty, chips, or a gel that can be injected through a syringe.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
HCT/P
true
Serial number
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00199150073504Medtronic Reusable InstrumentsEX12250012026-05-25
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00199150071753Medtronic Reusable InstrumentsEX02260402026-05-24
00199150071760Medtronic Reusable InstrumentsEX02260502026-05-24
00199150071777Medtronic Reusable InstrumentsEX02260602026-05-24

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