FDA.report

Bio2 Technologies

Primary DI
B01010000361
Brand
Bio2 Technologies
Company
BIO2 TECHNOLOGIES, INC.
Model
1000036
Device description
VITRIUM E 18 x 6
Published
2016-06-01
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
OISCalcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

Product Code Classifications

CodeDeviceSpecialtyClass
OISCalcium Salt Bone Void Filler, Drillable, Non-Screw AugmentationOrthopedic2

Premarket Submissions

SubmissionSupplement
K142463000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K142463000Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc.2014-12-18MQV

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B01010000361PrimaryHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
9999999999productinfo@bio2tech.com

Regulatory Flags

DUNS number
832629898
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B01010000351Bio2 Technologies10000352016-06-01
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
B01010000521Bio2 Technologies10000522016-06-01
B01010000531Bio2 Technologies10000532015-10-20
B01010000541Bio2 Technologies10000542015-10-20
B01010000551Bio2 Technologies10000552015-10-20

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Primary DIBrandCompanyProduct codePublished
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B4474410000REV0Mg OSTEOREVIVE® Bone Void FillerBONE SOLUTIONS, INC.OIS2022-02-02
B4474415000REV0Mg OSTEOREVIVE® Bone Void FillerBONE SOLUTIONS, INC.OIS2022-02-02
B4474405000INJ0Mg OSTEOINJECT® Bone Void FillerBONE SOLUTIONS, INC.OIS2022-01-11
B4474405000STR0OsteoCrete® Bone Void FillerBONE SOLUTIONS, INC.OIS2020-02-19
B4474410000BSI0OsteoCrete® Bone Void FillerBONE SOLUTIONS, INC.OIS2020-02-19
B4474410000STR0OsteoCrete® Bone Void FillerBONE SOLUTIONS, INC.OIS2020-02-19
B4474415000BSI0OsteoCrete® Bone Void FillerBONE SOLUTIONS, INC.OIS2020-02-19
B4474415000STR0OsteoCrete® Bone Void FillerBONE SOLUTIONS, INC.OIS2020-02-19
M263W21000WizardBio Resorbable Calcium Phosphate CementDSM BIOMEDICAL, INC.OIS2019-01-02
M263W23000WizardBio Resorbable Calcium Phosphate CementDSM BIOMEDICAL, INC.OIS2019-01-02
00812337029216BoneSync Fast-Setting Drillable Calcium Phosphate CementDSM BIOMEDICAL, INC.OIS2019-01-02
B4474405000BSI0OsteoCrete® Bone Void FillerBONE SOLUTIONS, INC.OIS2017-08-04
B01010000351Bio2 TechnologiesBIO2 TECHNOLOGIES, INC.OIS2016-06-01
B01010000371Bio2 TechnologiesBIO2 TECHNOLOGIES, INC.OIS2016-06-01
B01010000381Bio2 TechnologiesBIO2 TECHNOLOGIES, INC.OIS2016-06-01
B01010000391Bio2 TechnologiesBIO2 TECHNOLOGIES, INC.OIS2016-06-01
B01010000401Bio2 TechnologiesBIO2 TECHNOLOGIES, INC.OIS2016-06-01
B01010000411Bio2 TechnologiesBIO2 TECHNOLOGIES, INC.OIS2016-06-01
B01010000421Bio2 TechnologiesBIO2 TECHNOLOGIES, INC.OIS2016-06-01
B01010000431Bio2 TechnologiesBIO2 TECHNOLOGIES, INC.OIS2016-06-01
B01010000441Bio2 TechnologiesBIO2 TECHNOLOGIES, INC.OIS2016-06-01
B01010000451Bio2 TechnologiesBIO2 TECHNOLOGIES, INC.OIS2016-06-01
B01010000461Bio2 TechnologiesBIO2 TECHNOLOGIES, INC.OIS2016-06-01
B01010000471Bio2 TechnologiesBIO2 TECHNOLOGIES, INC.OIS2016-06-01
B01010000481Bio2 TechnologiesBIO2 TECHNOLOGIES, INC.OIS2016-06-01
B01010000491Bio2 TechnologiesBIO2 TECHNOLOGIES, INC.OIS2016-06-01
B01010000501Bio2 TechnologiesBIO2 TECHNOLOGIES, INC.OIS2016-06-01
B01010000511Bio2 TechnologiesBIO2 TECHNOLOGIES, INC.OIS2016-06-01