FDA.reportPublic FDA data

AlphaGRAFT

Primary DI
00840967110998
Brand
AlphaGRAFT
Company
ALPHATEC SPINE, INC.
Model
1001-010
Device description
AlphaGRAFT, Bone Matrix Gel, Demineralized, 1cc
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00840967110998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840967110998008409671109988409671109980840967110998

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
Total Volume1Milliliter

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
602465783
Device count
1
DM exempt
true
HCT/P
true
Serial number
true
Expiration date on label
true
Donation ID number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190376541471ATEC Lateral Navigation Disc Prep Instruments267-01-000-10-N2024-12-18
00190376529158ATEC Posterior Navigation Disc Prep Instruments244-01-000-06-N2024-04-20
00190376529189ATEC Posterior Navigation Disc Prep Instruments244-01-000-12-N2024-04-20
00190376476162ATEC Lateral Navigation Disc Prep Instruments266-01-000-08-N2023-08-26
00190376476179ATEC Lateral Navigation Disc Prep Instruments266-01-000-10-N2023-08-26
00190376476186ATEC Lateral Navigation Disc Prep Instruments266-01-000-12-N2023-08-26
00190376522906ATEC Lateral Navigation Disc Prep Instruments266-01-000-14-N2023-08-26
00840180512395General InstrumentsCI-11129-34242026-05-15
00840180543214General InstrumentsCI-118992026-05-15
00840180543542General InstrumentsCI-11915-302026-05-15
00840180544785General InstrumentsCI-11939-080-R2026-05-15
00840180544914General InstrumentsCI-11939-080-L2026-05-15
00840180545324General InstrumentsCI-11968-06-S2026-05-15
00840180545331General InstrumentsCI-11968-06-L2026-05-15
00840180545362General InstrumentsCI-11968-S2026-05-15
00840180545416General InstrumentsCI-11972-012026-05-15
00840180545423General InstrumentsCI-11972-032026-05-15
00840180545430General InstrumentsCI-11972-022026-05-15
00840180545447General InstrumentsCI-11972-042026-05-15
00840180545461General InstrumentsCI-11969-L2026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849777014052Union DBM, 1ccXtant Medical Holdings, Inc.MBP2026-06-24
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
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
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08809204338627TruForm+Hans Biomed Corp.MBP2017-07-18
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08809204338658TruForm+Hans Biomed Corp.MBP2017-07-18
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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