FDA.reportPublic FDA data

Bio2 Technologies

Primary DI
B01010000591
Brand
Bio2 Technologies
Company
BIO2 TECHNOLOGIES, INC.
Model
1000059
Device description
VITRIUM CMEDIUM, 6 x 20
Published
2015-10-20
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
B01010000591PrimaryHIBCC0

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
00816125027125VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
00816125027132VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
00816125027149VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
ECUR9920302VerteFramecurasan AGMQV2026-06-25
ECUR9920305VerteFramecurasan AGMQV2026-06-25
ECUR9920310VerteFramecurasan AGMQV2026-06-25
ECURCCLF25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF25250CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2512CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2525CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURTFF1050TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFF1100TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFM1050TriForm Moldable Foamcurasan AGMQV2026-06-25
ECURTFM1100TriForm Moldable Foamcurasan AGMQV2026-06-25
00849777014052Union DBM, 1ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014069Union DBM, 2.5ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014076Union DBM, 5ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014083Union DBM, 10ccXtant Medical Holdings, Inc.MQV2026-06-24
06429810349293Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349316Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349330Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349354Adaptos®FuseBiomendex OyMQV2026-06-24
W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.MQV2026-06-05
07610221017829Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017836Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017843Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017850Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01