FDA.reportPublic FDA data

GRAFTYS® QUICKSET KIT

Primary DI
03760191133983
Brand
GRAFTYS® QUICKSET KIT
Company
NORAKER
Model
QSMKITUSV1Q5
Catalog number
QSMKITUSV1Q5
Device description
Injectable Macroporous Calcium Phosphate - QUICKSET KIT, 5cc
Published
2026-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093343000
K231714000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093343000GRAFTY QUICKSETGraftys2010-04-22MQV
K231714000Graftys QuicksetGraftys2023-07-12MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760191133983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760191133983037601911339833760191133983

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, synthetic, non-antimicrobialA bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
279959048
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760191133723GlassBone Granules1-3 mm; 5ccGB1.3/52026-05-27
03760191133730GlassBone Granules1-3 mm; 10ccGB1.3/102026-05-27
03760191133747GlassBone Granules1-3 mm; 16ccGB1.3/162026-05-27
03760191133754GlassBone Granules0.5-1mm; 5ccGB05.1/52026-05-27
03760191133761GlassBone Granules1-3 mm; 1ccGB1.3/1-U2026-05-27
03760191133778GlassBone Granules0.5-1mm; 1ccGB05.1/1-U2026-05-27
03760191133785GlassBone Granules0.5-1mm; 0.5ccGB05.1/05-U2026-05-27
03760191134812AktiBone Granules0.5-1mm; 0.5ccXAK-GM0.52026-05-27
03760191134829AktiBone Granules0.5-1mm; 1ccXAK-GM1.02026-05-27
03760191134836AktiBone Granules0.5-1mm; 5ccXAK-GM52026-05-27
03760191134843AktiBone Granules1-3 mm; 1ccXAK-GL1.02026-05-27
03760191134850AktiBone Granules1-3 mm; 5ccXAK-GL52026-05-27
03760191134867AktiBone Granules1-3 mm; 10ccXAK-GL102026-05-27
03760191134874AktiBone Granules1-3 mm; 16ccXAK-GL162026-05-27
03760191134881MectaBlast Granules0.5-1mm; 0.5ccXMB-GM0.52026-05-27
03760191134898MectaBlast Granules0.5-1mm; 1ccXMB-GM1.02026-05-27
03760191134904MectaBlast Granules0.5-1mm; 5ccXMB-GM52026-05-27
03760191134911MectaBlast Granules1-3 mm; 1ccXMB-GL1.02026-05-27
03760191134928MectaBlast Granules1-3 mm; 5ccXMB-GL52026-05-27
03760191134935MectaBlast Granules1-3 mm; 10ccXMB-GL102026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760191133723GlassBone GranulesNORAKERMQV2026-05-27
03760191133730GlassBone GranulesNORAKERMQV2026-05-27
03760191133747GlassBone GranulesNORAKERMQV2026-05-27
03760191133754GlassBone GranulesNORAKERMQV2026-05-27
03760191133761GlassBone GranulesNORAKERMQV2026-05-27
03760191133778GlassBone GranulesNORAKERMQV2026-05-27
03760191133785GlassBone GranulesNORAKERMQV2026-05-27
03760191134812AktiBone GranulesNORAKERMQV2026-05-27
03760191134829AktiBone GranulesNORAKERMQV2026-05-27
03760191134836AktiBone GranulesNORAKERMQV2026-05-27
03760191134843AktiBone GranulesNORAKERMQV2026-05-27
03760191134850AktiBone GranulesNORAKERMQV2026-05-27
03760191134867AktiBone GranulesNORAKERMQV2026-05-27
03760191134874AktiBone GranulesNORAKERMQV2026-05-27
03760191134881MectaBlast GranulesNORAKERMQV2026-05-27
03760191134898MectaBlast GranulesNORAKERMQV2026-05-27
03760191134904MectaBlast GranulesNORAKERMQV2026-05-27
03760191134911MectaBlast GranulesNORAKERMQV2026-05-27
03760191134928MectaBlast GranulesNORAKERMQV2026-05-27
03760191134935MectaBlast GranulesNORAKERMQV2026-05-27
03760191134942MectaBlast GranulesNORAKERMQV2026-05-27
M263W21000WizardBio Resorbable Calcium Phosphate CementDSM BIOMEDICAL, INC.MQV2019-01-02
M263W23000WizardBio Resorbable Calcium Phosphate CementDSM BIOMEDICAL, INC.MQV2019-01-02
08719699710122MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710276MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710283MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710290MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710306MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710313MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710320MagnetOsKuros Biosciences B.V.MQV2018-01-08