INTERFACE IFBG100

GUDID 00816986020037

INTERFACE is a synthetic bioactive bone graft for use in the repair of osseous defects. It is supplied as irregular synthetic granules of bioactive glass (45S5 Bioglass), sized from 200 microns to 420 microns. When implanted in living tissue, the material undergoes a time dependent surface modification. The surface reaction results in the formation of a calcium phosphate layer, which is equivalent in composition and structure to the hydroxyapatite found in bone mineral. The biological apatite layer of the granules provides an osteoconductive scaffold for the generation of new osseous tissue. New bone infiltrates around the granules allowing the repair of the defect as the granules are absorbed.

BIOVENTUS LLC

Synthetic bone graft
Primary Device ID00816986020037
NIH Device Record Key8b86d02c-3c78-48da-b8eb-fb5dbc4bb8a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTERFACE
Version Model NumberIFBG100
Catalog NumberIFBG100
Company DUNS078450878
Company NameBIOVENTUS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-637-4391
EmailCSSurgical@bioventusglobal.com
Phone800-637-4391
EmailCSSurgical@bioventusglobal.com
Phone800-637-4391
EmailCSSurgical@bioventusglobal.com
Phone800-637-4391
EmailCSSurgical@bioventusglobal.com
Phone800-637-4391
EmailCSSurgical@bioventusglobal.com
Phone800-637-4391
EmailCSSurgical@bioventusglobal.com
Phone800-637-4391
EmailCSSurgical@bioventusglobal.com
Phone800-637-4391
EmailCSSurgical@bioventusglobal.com
Phone800-637-4391
EmailCSSurgical@bioventusglobal.com
Phone800-637-4391
EmailCSSurgical@bioventusglobal.com
Phone800-637-4391
EmailCSSurgical@bioventusglobal.com
Phone800-637-4391
EmailCSSurgical@bioventusglobal.com
Phone800-637-4391
EmailCSSurgical@bioventusglobal.com
Phone800-637-4391
EmailCSSurgical@bioventusglobal.com
Phone800-637-4391
EmailCSSurgical@bioventusglobal.com
Phone800-637-4391
EmailCSSurgical@bioventusglobal.com

Device Dimensions

Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram
Weight1 Gram

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816986020037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-14
Device Publish Date2019-05-06

Devices Manufactured by BIOVENTUS LLC

10389130444418 - SUPARTZ FX sodium hyaluronate2023-10-06 SUPARTZ FX (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respon
M937710346601 - EXOGEN Metatarsal Strap2021-12-27
00816986020488 - SIGNAFUSE Bioactive Bone Graft2020-08-07 SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glas
00816986020495 - SIGNAFUSE Bioactive Bone Graft2020-08-07 SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glas
00816986020501 - SIGNAFUSE Bioactive Bone Graft2020-08-07 SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glas
00816986020518 - SIGNAFUSE Bioactive Bone Graft2020-08-07 SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glas
00816986020006 - SIGNAFUSE2020-03-20 Bioactive Bone Graft Putty
00816986020013 - SIGNAFUSE2020-03-20 Bioactive Bone Graft Putty

Trademark Results [INTERFACE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTERFACE
INTERFACE
97494900 not registered Live/Pending
Stratia Inc.
2022-07-08
INTERFACE
INTERFACE
97048941 not registered Live/Pending
WS Acquisition, LLC
2021-09-28
INTERFACE
INTERFACE
90895390 not registered Live/Pending
RAMSEY BEN
2021-08-21
INTERFACE
INTERFACE
90172211 not registered Live/Pending
The Interface Collective LLC
2020-09-10
INTERFACE
INTERFACE
88373835 not registered Live/Pending
Interface, Inc.
2019-04-05
INTERFACE
INTERFACE
88349165 not registered Live/Pending
Payjo, Inc.
2019-03-20
INTERFACE
INTERFACE
88283629 not registered Live/Pending
INTERFACE FILMS LLC
2019-01-31
INTERFACE
INTERFACE
87780538 not registered Live/Pending
Storace, Paul
2018-02-01
INTERFACE
INTERFACE
87724845 5564251 Live/Registered
Interface, Inc.
2017-12-18
INTERFACE
INTERFACE
87708355 5534018 Live/Registered
Interface, Inc.
2017-12-05
INTERFACE
INTERFACE
87620636 5453163 Live/Registered
Dalton Maag Ltd
2017-09-25
INTERFACE
INTERFACE
86307830 4918827 Live/Registered
Comfort Lab Inc.
2014-06-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.