SIGNAFUSE Bioactive Bone Graft

FDA UDI

Class II (US FDA UDI)

by Bioventus Llc

Identity

Trade Name: SIGNAFUSE Bioactive Bone Graft FDA UDI
Generic Name: Synthetic bone graft FDA UDI
Device Name: SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process. FDA UDI
Model / Reference: 50X25X8 MM, 10 CC FDA UDI
Description: SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process. FDA UDI

Identifiers

Catalog Number: SGFS-010 FDA UDI
Primary DI / UDI-DI: 00816986020495 FDA UDI
510(k) Number: K193513 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

Category: Synthetic bone graft

SIGNAFUSE Bioactive Bone Graft by Bioventus Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Bicera® Resorbable Bone Substitute — WILTROM INC. · Class II

Cleared under the same submission

K193513 also covers:

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

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Manufacturer

Manufacturer: Bioventus Llc

Sources (1)

FDA UDI afa7e5a3-f627-4a21-9f3e-fa3bedac3495 37 fields · synced May 30, 2026