FDA.reportPublic FDA data

MagnetOs

Primary DI
08719699710276
Brand
MagnetOs
Company
Kuros Biosciences B.V.
Model
703-046-US
Device description
MagnetOs Granules 40cc 2-4mm USA
Published
2018-01-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K161859000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161859000MagnetOsXpand Biotechnology BV2017-02-24MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719699710276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719699710276087196997102768719699710276

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, compositeA sterile bioabsorbable device made of synthetic bone substitute materials (e.g., ceramics such as tricalcium phosphate or hydroxyapatite) combined with bone growth factors (e.g., bovine collagen) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume4Centiliter

Regulatory Flags#

DUNS number
412689114
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719699712201MagnetOs703-060-US2025-06-19
08719699712218MagnetOs703-061-US2025-06-19
08719699712072MagnetOs703-047-US2022-09-29
08719699712089MagnetOs703-048-US2022-09-29
08719699712096MagnetOs703-049-US2022-09-29
08719699712102MagnetOs703-050-US2022-09-29
08719699712119MagnetOs703-051-US2022-09-29
08719699712126MagnetOs703-052-US2022-09-29
08719699712133MagnetOs703-053-US2022-09-29
08719699712140MagnetOs703-054-US2022-09-29
08719699712157MagnetOs703-055-US2022-09-29
08719699712195MagnetOs703-059-US2022-09-21
08719699710160MagnetOs703-017-US2018-01-08
08719699710177MagnetOs703-018-US2018-01-08
08719699710184MagnetOs703-019-US2018-01-08
08719699710191MagnetOs703-020-US2018-01-08
08719699710207MagnetOs703-021-US2018-01-08
08719699710214MagnetOs703-022-US2018-01-08
08719699710221MagnetOs703-023-US2018-01-08
08719699710238MagnetOs703-024-US2018-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
08719699710337MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710344MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710351MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710368MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710375MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710382MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710399MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710405MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710412MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710436MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710443MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710450MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710429MagnetOsKuros Biosciences B.V.MQV2018-01-05
08809204338580TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338597TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338603TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338610TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338627TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338634TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338641TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338658TruForm+Hans Biomed Corp.MQV2017-07-18
08809204338665TruForm+Hans Biomed Corp.MQV2017-07-18