FDA.report

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
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MBPFiller, bone void, osteoinduction (w/o human growth factor)

Product Code Classifications

CodeDeviceSpecialtyClass
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)Orthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840967110998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840967110998008409671109988409671109980840967110998

GMDN Terms

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

TypeValueUnit
Total Volume1Milliliter

Sterilization Methods

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

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