FDA.reportPublic FDA data

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

Primary DI
00613994985668
Brand
GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
P45001
Device description
DBM P45001 1CC PASTE GRAFTON PLUS
Published
2015-07-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00613994985668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994985668006139949856686139949856680613994985668

GMDN Terms#

Term, Definition table
TermDefinition
Human-derived demineralized bone matrix implantAn 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

Contacts#

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

Regulatory Flags#

DUNS number
830350380
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150076451Medtronic Reusable InstrumentsX36902502026-10-19
00199150080373Medtronic Reusable InstrumentsX02260452026-10-19
00199150080380Medtronic Reusable InstrumentsX02260462026-10-19
00199150080397Medtronic Reusable InstrumentsX02260472026-10-19
00199150080403Medtronic Reusable InstrumentsX02260502026-10-19
00824846003922Medtronic Reusable InstrumentsEX06260022026-10-19
00824846013082Medtronic Reusable InstrumentsX09074302026-10-19
00824846013600Medtronic Reusable InstrumentsX07260042026-10-19
00763000750053CD HORIZON® Fenestrated Screw Spinal System557510245402026-10-16
00763000750251CD HORIZON® Fenestrated Screw Spinal System557510255302026-10-16
00763000750268CD HORIZON® Fenestrated Screw Spinal System557510255352026-10-16
00763000750275CD HORIZON® Fenestrated Screw Spinal System557510255402026-10-16
00763000750374CD HORIZON® Fenestrated Screw Spinal System557510265352026-10-16
00763000750404CD HORIZON® Fenestrated Screw Spinal System557510265502026-10-16
00824846010739Medtronic Reusable InstrumentsX06260032026-10-18
00824846013495Medtronic Reusable InstrumentsEX07260062026-10-18
00763000786458CD HORIZON® Fenestrated Screw Spinal System65411012026-10-15
00643169236967n/a74806532026-10-11
00643169236974n/a74806522026-10-11
00643169236981n/a74806512026-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169964938GRAFTON™ DBMMEDTRONIC SOFAMOR DANEK, INC.MBP2024-12-05
00643169965102GRAFTON PLUS™ DBMMEDTRONIC SOFAMOR DANEK, INC.MBP2024-11-15
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
00763000140502PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MBP2021-03-12
00763000140519PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MBP2021-03-12
00763000140526PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MBP2021-03-12
00763000140533PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.MBP2021-03-12
00613994247612PROGENIX® PUTTY and PROGENIX® PLUSMEDTRONIC SOFAMOR DANEK, INC.MBP2019-03-29
00643169965089GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.MBP2019-02-07
00643169965096GRAFTON PLUS® DBMMEDTRONIC SOFAMOR DANEK, INC.MBP2018-04-05
00643169965065GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.MBP2018-01-26
00849777004695ProSpace™ DBM Paste (Syringe)Xtant Medical Holdings, Inc.MBP2016-10-18
00849777004701ProSpace™ DBM Paste (Syringe)Xtant Medical Holdings, Inc.MBP2016-10-18
00849777004718ProSpace™ DBM Paste (Syringe)Xtant Medical Holdings, Inc.MBP2016-10-18
00849777004725ProSpace™ DBM Moldable Putty (Jar)Xtant Medical Holdings, Inc.MBP2016-10-18
00849777004732ProSpace™ DBM Moldable Putty (Jar)Xtant Medical Holdings, Inc.MBP2016-10-18
00849777004749ProSpace™ DBM Moldable Putty (Jar)Xtant Medical Holdings, Inc.MBP2016-10-18
00849777004824DBM Putty 2.5cc in a SyringeXtant Medical Holdings, Inc.MBP2016-10-18
00849777004831DBM Putty 5.0cc in a SyringeXtant Medical Holdings, Inc.MBP2016-10-18
00849777005630DBM Putty 10.0cc, AxograftXtant Medical Holdings, Inc.MBP2016-10-18
00849777005647DBM Putty 1.0cc, AxograftXtant Medical Holdings, Inc.MBP2016-10-18
00849777005654DBM Putty 2.5cc, AxograftXtant Medical Holdings, Inc.MBP2016-10-18
00849777005661DBM Putty 5.0cc, AxograftXtant Medical Holdings, Inc.MBP2016-10-18