FDA.reportPublic FDA data

INTERFACE

Primary DI
00816986020037
Brand
INTERFACE
Company
BIOVENTUS LLC
Model
IFBG100
Catalog number
IFBG100
Device description
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.
Published
2019-05-06
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112857000
K132071000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112857000INTERFACE BONE VOID FILLERBiostructures, LLC2011-12-13MQV
K132071000BIOACTIVE BONE GRAFT PUTTYBiostructures, LLC2014-01-10MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816986020037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816986020037008169860200378169860200370816986020037

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight1Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-637-4391CSSurgical@bioventusglobal.com

Regulatory Flags#

DUNS number
078450878
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M937710346601EXOGEN Metatarsal Strap710346602021-12-17
M937710344001EXOGEN® Ultrasound Bone Healing System71034400710344002017-01-12
M937710346001EXOGEN® Ultrasound Bone Healing System71034600710346002017-01-12
00816986020549TalisMann Implant KitTM-10002025-09-01
00816986020556StimTrial Surgical KitTS-10002025-09-01
00816986020570StimTrial Patient KitTS-60002025-09-01
00816986020587StimTrial Stimulator KitTS-50002025-09-01
00816986020617Bioventus User KitPNS-50002025-09-01
00816986020624Bioventus Clinician KitPNS-10002025-09-01
10389130444418SUPARTZ FX sodium hyaluronate715644442023-09-28
00816986020525Osteoamp Flowable Access CannulaOFAC-COFAC-C2024-11-21
00816986020488SIGNAFUSE Bioactive Bone Graft25X25X8 MM, 5 CCSGFS-0052020-07-30
00816986020495SIGNAFUSE Bioactive Bone Graft50X25X8 MM, 10 CCSGFS-0102020-07-30
00816986020501SIGNAFUSE Bioactive Bone Graft100X25X8 MM, 20 CCSGFS-0202020-07-30
00816986020518SIGNAFUSE Bioactive Bone Graft200X25X8 MM, 40 CCSGFS-0402020-07-30
00816986020006SIGNAFUSE15gSGF-1502019-02-22
00816986020013SIGNAFUSE7.5gSGF-0752019-02-22
00816986020020SIGNAFUSE3.75gSGF-0372019-02-22
00816986020082OSTEOFUSE3.75gOF0012019-02-22
00816986020099OSTEOFUSE7.5gOF0022019-02-22

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Primary DI, Brand, Company table
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