GRAFTON PLUS® DBM

Primary DI
00643169134386
Brand
GRAFTON PLUS® DBM
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
T45005INT
Device description
DBM T45005INT 5CC PASTE GRAFTON PLUS
Published
2016-04-03
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)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043048000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169134386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169134386006431691343866431691343860643169134386

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
00199150076161Medtronic Reusable InstrumentsX02260412026-06-05
00199150076178Medtronic Reusable InstrumentsX02260422026-06-05
00199150080304Medtronic Reusable InstrumentsX08032922026-06-05
00199150077359Medtronic Reusable InstrumentsEX02260492026-06-01
00199150077366Medtronic Reusable InstrumentsEX02260512026-06-01
00763000857844T2 STRATOSPHERE™ Expandable Corpectomy System43612552026-06-01
00763000857943T2 STRATOSPHERE™ Expandable Corpectomy System43612202026-06-01
00763000857998T2 STRATOSPHERE™ Expandable Corpectomy System43613082026-06-01
00763000881252Clydesdale™ Spinal System49860402026-05-29
00199150073504Medtronic Reusable InstrumentsEX12250012026-05-25
00199150071685Medtronic Reusable InstrumentsEX02261402026-05-24
00199150071692Medtronic Reusable InstrumentsEX02261502026-05-24
00199150071708Medtronic Reusable InstrumentsEX02261602026-05-24
00199150071715Medtronic Reusable InstrumentsEX02261702026-05-24
00199150071722Medtronic Reusable InstrumentsEX02261802026-05-24
00199150071739Medtronic Reusable InstrumentsEX02261902026-05-24
00199150071746Medtronic Reusable InstrumentsEX02262002026-05-24
00199150071753Medtronic Reusable InstrumentsEX02260402026-05-24
00199150071760Medtronic Reusable InstrumentsEX02260502026-05-24
00199150071777Medtronic Reusable InstrumentsEX02260602026-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810076560007BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560380BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560649BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560656BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560663BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560670BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560687BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560694BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
08809204338580TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338597TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338603TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338610TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338627TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338634TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338641TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338658TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338665TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338672TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338689TruFormHans Biomed Corp.MBP2017-07-18
08809204338696TruFormHans Biomed Corp.MBP2017-07-18
08809204338702TruFormHans Biomed Corp.MBP2017-07-18
08809204338719TruFormHans Biomed Corp.MBP2017-07-18
08809204338726TruFormHans Biomed Corp.MBP2017-07-18
08809204338733TruFormHans Biomed Corp.MBP2017-07-18
08809204338740TruFormHans Biomed Corp.MBP2017-07-18
08809204338757TruFormHans Biomed Corp.MBP2017-07-18
08809204338764TruFormHans Biomed Corp.MBP2017-07-18
08809204338771TruFormHans Biomed Corp.MBP2017-07-18
08809204338498ExponentHans Biomed Corp.MBP2017-03-09
10885862094827OptecureExactech, Inc.MBP2016-09-19