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BIOVENTUS LLC

Last updated September 17, 2026

Information

Country: US
Address: 4721 Emperor Blvd Ste 100, Durham, NC, 27703
Website: bioventusglobal.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-800-836-4080
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3009595577
DUNS Number: 078450878

Catalogue (38)

Device	Model / Reference	Registries	Class	Status
UNITE Bioactive Bone Graft	15g	FDA UDI	Class II	Active
TalisMann Implant Kit	TM-1000	FDA UDI	Class II	Active
Osteoamp Flowable Access Cannula	OFAC-C	FDA UDI	Class II	Active
SIGNAFUSE Bioactive Bone Graft	25X25X8 MM, 5 CC	FDA UDI	Class II	Active
Interface	IFBG100	FDA UDI	Class II	Active
SIGNAFUSE Bioactive Bone Graft	200X25X8 MM, 40 CC	FDA UDI	Class II	Active
Osteomatrix+	9cc	FDA UDI	Class II	Active
SUPARTZ FX sodium hyaluronate	71564444	FDA UDI	Class III	Active
UNITE Bioactive Bone Graft	7.5g	FDA UDI	Class II	Active
EXOGEN® Ultrasound Bone Healing System	71034400	FDA UDI	Class III	Active
SIGNAFUSE Bioactive Bone Graft	100X25X8 MM, 20 CC	FDA UDI	Class II	Active
StimTrial Patient Kit	TS-6000	FDA UDI	Class II	Active
EXOGEN® Ultrasound Bone Healing System	71034600	FDA UDI	Class II	Active
Osteofuse	15g	FDA UDI	Class II	Active
SIGNAFUSE Bioactive Bone Graft	50X25X8 MM, 10 CC	FDA UDI	Class II	Active
Osteomatrix+	18cc	FDA UDI	Class II	Active
StimTrial Surgical Kit	TS-1000	FDA UDI	Class II	Active
Durolane	1082020	FDA UDI	Class III	Active
Signafuse	7.5g	FDA UDI	Class II	Active
Osteofuse	3.75g	FDA UDI	Class II	Active
UNITE Bioactive Bone Graft	3.75g	FDA UDI	Class II	Active
Bioventus Clinician Kit	PNS-1000	FDA UDI	Class II	Active
Osteofuse	7.5g	FDA UDI	Class II	Active
Signafuse	15g	FDA UDI	Class II	Active
StimTrial Stimulator Kit	TS-5000	FDA UDI	Class II	Active
Signafuse	3.75g	FDA UDI	Class II	Active
EXOGEN® Ultrasound Bone Healing System	71034601	FDA UDI	Class III	Active
EXOGEN Metatarsal Strap	71034660	FDA UDI	Class III	Active
Bioventus User Kit	PNS-5000	FDA UDI	Class II	Active
EXOGEN® Ultrasound Bone Healing System MOU	71034401	FDA UDI	Class III	Active
Allograft Delivery Device (OFAC-C)	K233368	FDA 510(k)	Class II	Active
StimTrial Neuromodulation System	K243782	FDA 510(k)	Class II	Active
MCS Bone Graft	K162860	FDA 510(k)	Class II	Active
SIGNAFUSE Bioactive Bone Graft	K193513	FDA 510(k)	Class II	Active
TalisMann Neuromodulation System	K243678	FDA 510(k)	Class II	Active
SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty	K233490	FDA 510(k)	Class II	Active
Durolane	P170007	FDA PMA	Class III	Active
EXOGEN Ultrasound Bone Healing System	P900009	FDA PMA	N/A	Active

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 17, 2020	Z-0810-2021	—	terminated	Product may contain white particulates that are microbial in nature.
Feb 13, 2019	Z-1148-2019	—	terminated	The firm became aware of the potential for the products' sterile pouch to be punctured during transit. The packaging failure may introduce a non-sterile device that may lead to patient infection.