FDA.reportPublic FDA data

BIO2 TECHNOLOGIES

Primary DI
B01010001321
Brand
BIO2 TECHNOLOGIES
Company
BIO2 TECHNOLOGIES, INC.
Model
100-0132
Device description
Vitrium PIP Standard Straight
Published
2017-05-12
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
HTYPin, Fixation, Smooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151876000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151876000Bio2 Fusion Implant SystemBio2 Technologies, Inc.2015-12-30HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B01010001321PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, bioabsorbableA device in the form of a small diameter rod used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis, in the presence of additional immobilization. The rod may be smooth or partially threaded. The device is made of a material that is chemically degraded and typically absorbed by natural body processes (e.g., degradable polymers such as polydioxanone or polyglycolide). 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
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
B01010000521Bio2 Technologies10000522016-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630894830822APTUSMedartis AGHTY2026-06-01
07630894830839APTUSMedartis AGHTY2026-06-01
07630894830884APTUSMedartis AGHTY2026-06-01
07630894830891APTUSMedartis AGHTY2026-06-01
07649990202419Drill S-PI-A1.6 extra shortSurgical Fusion Technologies GmbHHTY2026-01-18
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHHTY2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHHTY2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHHTY2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHHTY2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHHTY2025-10-01
07630037863977APTUSMedartis AGHTY2025-07-31
07630037863984APTUSMedartis AGHTY2025-07-31
07630037864011APTUSMedartis AGHTY2025-04-08
07630037864264APTUSMedartis AGHTY2025-04-08
07613327084191STEINMANNStryker GmbHHTY2025-01-09
09353903030003Griplasty SystemFIELD ORTHOPAEDICS PTY LTDHTY2024-09-19
07649990202075SupraFuser GeneratorSurgical Fusion Technologies GmbHHTY2024-04-12
07649990202228SF Push-in Anchor 1.6Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202235SF Push-in Anchor 3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202259Stopper S-PI-A1.6Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202266Stopper S-PI-A2.3Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202273Stopper S-PI-A3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202297Guide S-PI / W5.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202303Sonotrode S-PISurgical Fusion Technologies GmbHHTY2024-04-12
07649990202310Drill S-PI-A1.6Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202327Drill S-PI-A2.3Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202334Drill S-PI-A3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202365Tray SF Push-in Anchor PortfolioSurgical Fusion Technologies GmbHHTY2024-04-12
07630037863854APTUSMedartis AGHTY2024-03-22
07630037863915APTUSMedartis AGHTY2024-03-22