FDA.reportPublic FDA data

Bio2 Technologies

Primary DI
B01010000521
Brand
Bio2 Technologies
Company
BIO2 TECHNOLOGIES, INC.
Model
1000052
Device description
VITRIUM E22 x 10
Published
2016-06-01
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQVFiller, Bone Void, Calcium Compound
OISCalcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2
OISCalcium Salt Bone Void Filler, Drillable, Non-Screw AugmentationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142463000
K152589000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142463000Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc.2014-12-18MQV
K152589000Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc.2016-01-12MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B01010000521PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic bone graftAn artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9999999999productinfo@bio2tech.com

Regulatory Flags#

DUNS number
832629898
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B01010001291BIO2 TECHNOLOGIES100-01292017-05-12
B01010001301BIO2 TECHNOLOGIES100-01302017-05-12
B01010001321BIO2 TECHNOLOGIES100-01322017-05-12
B01010000351Bio2 Technologies10000352016-06-01
B01010000361Bio2 Technologies10000362016-06-01
B01010000371Bio2 Technologies10000372016-06-01
B01010000381Bio2 Technologies10000382016-06-01
B01010000391Bio2 Technologies10000392016-06-01
B01010000401Bio2 Technologies10000402016-06-01
B01010000411Bio2 Technologies10000412016-06-01
B01010000421Bio2 Technologies10000422016-06-01
B01010000431Bio2 Technologies10000432016-06-01
B01010000441Bio2 Technologies10000442016-06-01
B01010000451Bio2 Technologies10000452016-06-01
B01010000461Bio2 Technologies10000462016-06-01
B01010000471Bio2 Technologies10000472016-06-01
B01010000481Bio2 Technologies10000482016-06-01
B01010000491Bio2 Technologies10000492016-06-01
B01010000501Bio2 Technologies10000502016-06-01
B01010000511Bio2 Technologies10000512016-06-01

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
M263W25000WizardBio Resorbable Calcium Phosphate CementDSM BIOMEDICAL, INC.OIS2019-01-02
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