FDA.reportPublic FDA data

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

Primary DI
00613994985644
Brand
GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
P45010
Device description
DBM P45010 10CC 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
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
00613994985644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994985644006139949856446139949856440613994985644

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
Lot or batch
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00721902975158GDLH® Posterior Spinal SystemX0196-1112015-08-05
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00721902975219GDLH® Posterior Spinal SystemX0196-1262015-08-05
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00721902975233GDLH® Posterior Spinal SystemX0196-1302015-08-05
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00673978130347GDLH® Posterior Spinal SystemX0196-1072015-08-24
00673978130361GDLH® Posterior Spinal SystemX0196-1092015-08-24
00673978130385GDLH® Posterior Spinal SystemX0196-1122015-08-23
00673978130392GDLH® Posterior Spinal SystemX0196-1142015-08-24
00673978130408GDLH® Posterior Spinal SystemX0196-1162015-08-24
00673978130415GDLH® Posterior Spinal SystemX0196-1182015-08-24
00673978130422GDLH® Posterior Spinal SystemX0196-1202015-08-24
00763000992316INFINITY™ Occipitocervical Upper Thoracic SystemG365PT35262026-07-24
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00849777014069Union DBM, 2.5ccXtant Medical Holdings, Inc.MBP2026-06-24
00849777014076Union DBM, 5ccXtant Medical Holdings, Inc.MBP2026-06-24
00849777014083Union DBM, 10ccXtant Medical Holdings, Inc.MBP2026-06-24
00810076560007BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
00810076560380BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
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00810076560656BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
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00810076560670BiomaXXtant Medical Holdings, Inc.MBP2021-11-02
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