FDA.reportPublic FDA data

AlphaGRAFT

Primary DI
00844856026711
Brand
AlphaGRAFT
Company
ALPHATEC SPINE, INC.
Model
1001-050
Device description
AlphaGRAFT, Bone Matrix Gel, Demineralized, 5cc
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844856026711PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844856026711008448560267118448560267110844856026711

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
Total Volume0

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
602465783
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
true
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840967110981AlphaGRAFT1002-1002015-09-24
00840967110998AlphaGRAFT1001-0102015-09-24
00840967111001AlphaGRAFT1001-1002015-09-24
00844856026728AlphaGRAFT1002-0252015-09-24
00844856026735AlphaGRAFT1002-0502015-09-24
00844856032231Osseofix +213902016-10-28
00190376649474CONTOUR3DAIX761032026-09-25
00190376652313CONTOUR3DAIX761012026-09-25
00190376652320CONTOUR3DAIX761022026-09-25
00190376652337CONTOUR3DAIX761042026-09-25
00190376668307CONTOUR3DAIX760002026-09-25
00190376733470CONTOUR3DC3DRODA2026-09-25
00190376778372InvictusVMRIN2026-08-19
00190376778396InvictusVMTIN2026-08-19
00190376768847Invictus171442026-08-17
00190376544397Invictus17920-012026-07-30
00190376544403Invictus17920-022026-07-30
00190376544410Invictus17920-032026-07-30
00190376544427Invictus17920-042026-07-30
00190376544434Invictus17920-052026-07-30

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