FDA.reportPublic FDA data

GRAFTON® DBM

Primary DI
00643169965003
Brand
GRAFTON® DBM
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
T43110INT
Device description
DBM T43110INT 10CC GRAFTON PUTTY
Published
2018-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUNBONE GRAFTING MATERIAL, HUMAN SOURCE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUNBone Grafting Material, Human SourceDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051188000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051188000GRAFTON DBMOsteotech, Inc.2006-01-03NUN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169965003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169965003006431699650036431699650030643169965003

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
00763000992521INFINITY OCT SystemG36535102026-09-26
00763000992552INFINITY OCT SystemG36535162026-09-26
00643169016798Medtronic Reusable InstrumentsX06110012022-11-27
00643169016804Medtronic Reusable InstrumentsX06110022022-11-27
00673978816241Medtronic Reusable InstrumentsX06990402022-11-27
00613994423559N/AX07072142022-11-14
00613994423566N/AX07072152022-11-14
00613994423573N/AX07072162022-11-14
00613994423603N/AX07072192022-11-14
00643169588219Medtronic Resuable InstrumentsX08108352022-11-14
00643169860940Medtronic Resuable InstrumentsX07160322022-11-14
00643169860957Medtronic Resuable InstrumentsX07160332022-11-14
00613994107169Medtronic Reusable InstrumentsX08050732022-10-07
00613994230676Medtronic Reusable InstrumentsX07061412022-10-07
00613994404510Medtronic Reusable InstrumentsX07061942022-10-07
00613994507129Medtronic Reusable InstrumentsX08081362022-10-07
00613994507150Medtronic Reusable InstrumentsX08081392022-10-07
00613994507174Medtronic Reusable InstrumentsX08081412022-10-07
00613994838797Medtronic Reusable InstrumentsX06102712022-10-07
00613994838803Medtronic Reusable InstrumentsX06102702022-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809963478848SurFuse II PuttyHans Biomed Corp.NUN2026-04-16
08809963478855SurFuse II PuttyHans Biomed Corp.NUN2026-04-16
08809963478862SurFuse II PuttyHans Biomed Corp.NUN2026-04-16
08809963478879ExFuse II PuttyHans Biomed Corp.NUN2026-04-16
08809963478886ExFuse II PuttyHans Biomed Corp.NUN2026-04-16
08809963478893ExFuse II PuttyHans Biomed Corp.NUN2026-04-16
00841336138766Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNUN2025-09-28
00841336138773Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNUN2025-09-28
00841336138797Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNUN2025-09-28
00841336138803Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNUN2025-09-28
00841336114395Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNUN2024-12-11
00841336136229Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNUN2024-12-11
00841336138780Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNUN2024-12-11
00643169964938GRAFTON™ DBMMEDTRONIC SOFAMOR DANEK, INC.NUN2024-12-05
00841336111905Allo-3D-PlusSALVIN DENTAL SPECIALTIES, LLCNUN2024-07-11
00841336111912Allo-3D-PlusSALVIN DENTAL SPECIALTIES, LLCNUN2024-07-11
00191083045092RegenaVate™ Formable DBM, 1cm x 4cm x 0.5cm, 2ccRti Surgical, Inc.NUN2024-05-27
00191083045108RegenaVate™ Formable DBM RT, 1ccRti Surgical, Inc.NUN2024-05-27
00191083045078RegenaVate™ Formable DBM, 1cm x 1cm x 0.5cm, 0.5ccRti Surgical, Inc.NUN2024-05-27
00191083045085RegenaVate™ Formable DBM, 1cm x 2cm x 0.5cm, 1ccRti Surgical, Inc.NUN2024-05-27
00191083045115RegenaVate™ Formable DBM RT, 2ccRti Surgical, Inc.NUN2024-05-27
00763000140540PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.NUN2021-03-12
00763000140557PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.NUN2021-03-12
00763000140564PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.NUN2021-03-12
00763000140571PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.NUN2021-03-12
00643169964952GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.NUN2018-07-12
00643169964990GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.NUN2018-06-11
00841336100220ALLO-0.5SALVIN DENTAL SPECIALTIES, LLCNUN2018-02-22
00841336100237ALLO-1.0SALVIN DENTAL SPECIALTIES, LLCNUN2018-02-22
00841336100244ALLO-2.0SALVIN DENTAL SPECIALTIES, LLCNUN2018-02-22