Interface

FDA UDI

Class II (US FDA UDI)

by Bioventus Llc

Identity

Trade Name: INTERFACE FDA UDI
Generic Name: Synthetic bone graft FDA UDI
Device Name: 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. FDA UDI
Model / Reference: IFBG100 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: IFBG100 FDA UDI
Primary DI / UDI-DI: 00816986020037 FDA UDI
510(k) Number: K112857 FDA UDI
K132071 FDA UDI
FDA Product Code: MQV FDA UDI
GMDN Term: Synthetic bone graft FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3045 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 1 Gram FDA UDI

Category: Synthetic bone graft

Interface by Bioventus Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Synthetic bone graft.

Beta-bsm ® — Etex Corp. · Class II
BIO2 TECHNOLOGIES — Bio2 Technologies, Inc. · Class II
Bicera® Resorbable Bone Substitute — Wiltrom Co., Ltd. (Chutung) · Class II
OsseoSculpt Moldable ABG, 3cc — Biogennix, LLC · Class II
Montage Settable Bone Putty — ABYRX, INC. · Class II
IngeniOS HA — curasan AG · Class II
Osbone Dental — curasan AG · Class II
Bicera® Resorbable Bone Substitute — WILTROM INC. · Class II

Cleared under the same submission

K132071 also covers:

OSTEOFUSE — BIOVENTUS LLC
OSTEOFUSE — BIOVENTUS LLC
OSTEOFUSE — BIOVENTUS LLC
SIGNAFUSE — BIOVENTUS LLC
SIGNAFUSE — BIOVENTUS LLC
SIGNAFUSE — BIOVENTUS LLC
UNITE Bioactive Bone Graft — BIOVENTUS LLC
UNITE Bioactive Bone Graft — BIOVENTUS LLC
UNITE Bioactive Bone Graft — BIOVENTUS LLC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Bioventus Llc

Sources (1)

FDA UDI 8b86d02c-3c78-48da-b8eb-fb5dbc4bb8a5 38 fields · synced May 30, 2026