BIOVENTUS LLC

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• bioventusglobal.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMA#

• DUROLANE

  2022-10-14

  Bioventus LLC4721 Emperor Blvd, Suite 100durham, NC 27703 PMA NumberP170007 Supplement NumberS014 Date Received09/14/2022 Decision Date10/14/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change -...

• Durolane

  2022-03-03

  Bioventus LLC4721 Emperor Blvd, Suite 100durham, NC 27703 PMA NumberP170007 Supplement NumberS013 Date Received02/03/2022 Decision Date03/03/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change -...

• DUROLANE

  2022-03-02

  Bioventus LLC4721 Emperor Blvd, Suite 100durham, NC 27703 PMA NumberP170007 Supplement NumberS012 Date Received02/03/2022 Decision Date03/02/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change -...

• DUROLANE

  2022-01-25

  Bioventus LLC

• Exogen

  2022-01-07

  BIOVENTUS LLC

• DUROLANE

  2021-12-22

  Bioventus LLC

• EXOGEN Ultrasound Bone Healing System

  2021-08-31

  BIOVENTUS LLC

• DUROLANE

  2021-05-25

  Bioventus LLC

• EXOGEN Ultrasound Bone Healing System

  2021-04-14

  BIOVENTUS LLC

• DUROLANE

  2020-11-29

  Bioventus LLC

• DUROLANE

  2020-10-21

  Bioventus LLC

• DUROLANE

  2020-10-08

  Bioventus LLC

• Exogen Ultrasound Bone Healing System

  2019-12-20

  BIOVENTUS LLC

• Durolane, Hyaluronic Acid, Stabilized Single Injection

  2019-12-18

  Bioventus LLC

• Durolane

  2019-09-19

  Bioventus LLC

• Durolane, Hyaluronic Acid, Stabilized Single Injection

  2019-06-08

  Bioventus LLC

• DUROLANE

  2019-03-13

  Bioventus LLC

• DUROLOANE

  2018-08-17

  Bioventus LLC

• EXOGEN Ultrasound Bone Healing System

  2018-05-22

  BIOVENTUS LLC

• EXOGEN Ultrasound Bone Healing System

  2017-09-11

  BIOVENTUS LLC

• DUROLANE

  2017-08-29

  Bioventus LLC

• EXOGEN ULTRASOUND BONE HEALING SYSTEM

  2017-01-12

  BIOVENTUS LLC

• EXOGEN ULTRASOUND BONE HEALING SYSTEM

  2015-04-22

  BIOVENTUS LLC

• EXOGEN ULTRASOUND BONE HEALING SYSTEM

  2014-12-08

  BIOVENTUS LLC

• EXOGEN ULTRASOUND BONE HEALING SYSTEM

  2014-08-21

  BIOVENTUS LLC

• EXOGEN ULTRASOUND BONE HEALING SYSTEM

  2014-05-29

  BIOVENTUS LLC

• EXOGEN ULTRASOUND BONE HEALING SYSTEM

  2014-05-07

  BIOVENTUS LLC

• ULTRASOUND BONE HEALING SYSTEM

  2012-06-06

  BIOVENTUS LLC

• EXOGEN 4000+

  2010-03-26

  BIOVENTUS LLC

• EXOGEN BONE HEALING SYSTEM

  2009-10-02

  BIOVENTUS LLC

• EXOGEN 4000+ BONE HEALING SYSTEM

  2009-03-13

  BIOVENTUS LLC

• EXOGEN BONE HEALING SYSTEM 2000 ,3000

  2008-12-19

  BIOVENTUS LLC

• EXOGEN 4000+BONE HEALING SYSTEM

  2008-12-18

  BIOVENTUS LLC

• EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)

  2007-08-16

  BIOVENTUS LLC

• EXOGEN 4000+BONE HEALING SYSTEM

  2007-08-16

  BIOVENTUS LLC

• EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)

  2007-06-11

  BIOVENTUS LLC

• EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)

  2006-11-01

  BIOVENTUS LLC

• EXOGEN 2000+ BONE HEALING SYSTEM

  2006-06-30

  BIOVENTUS LLC

• EXOGEN 4000+ BONE HEALING SYSTEM

  2006-06-26

  BIOVENTUS LLC

• EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) AND EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM

  2005-05-19

  BIOVENTUS LLC

58 records. Showing 1-40. Next

PMN#

• StimTrial Neuromodulation System

  2025-07-16

  Bioventus, LLC

• TalisMann Neuromodulation System

  2025-07-03

  Bioventus, LLC

• Allograft Delivery Device (OFAC-C)

  2024-06-25

  Bioventus, LLC

• SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty

  2023-12-05

  Bioventus, LLC

• SIGNAFUSE Bioactive Bone Graft

  2020-06-18

  Bioventus

• MCS Bone Graft

  2017-02-13

  BIOVENTUS LLC

GUDID#

• EXOGEN Metatarsal Strap - 71034660

  BIOVENTUS LLC

  2021-12-17

• EXOGEN® Ultrasound Bone Healing System - The EXOGEN Ultrasound Bone Healing System provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. EXOGEN is designed both for use with conservatively treated fresh fractures and non-unions, or surgically-treated non-unions. EXOGEN transmits a low-intensity ultrasound signal to the fracture site through coupling gel, with little or no sensation felt by the patient during the treatment. Low-intensity pulsedultrasound has been shown in in-vitro and in-vivo studies to stimulate cells to produce growth factors and proteins that are important to bone healing.The patient administers treatment at home or at work, once daily, for 20 minutes, or as prescribed by a physician. EXOGEN automatically alerts the patient in case of improper application or performance. The EXOGEN Ultrasound Bone Healing System consists of one EXOGEN device, a charger, a gel bottle and strap. The EXOGEN device provides the treatment control circuitry, the battery supply and monitors the operation of the transducer at the fracture site. Thesignal specifications cannot be changed.

  BIOVENTUS LLC

  2017-01-12

• EXOGEN® Ultrasound Bone Healing System - The EXOGEN device provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. The EXOGEN Ultrasound Bone Healing Systems has been designed both for use with conservatively treated fresh fractures and non-unions or surgically treated non-unions. The device transmits a low intensity ultrasound signal to the fracture site through coupling gel, with little or no sensation felt by the patient during the treatment. The low-intensity pulsed ultrasound has been shown in in-vitro and in-vivo studies to stimulate cells to produce growth factors and proteins that are important to bone healing. The patient administers treatment at home or at work, once daily, for 20 minutes, or as prescribed by a physician. The device automatically alerts the patient in case of improper application or device performance. The EXOGEN Ultrasound Bone Healing System consists of one main operating unit, gel bottles and strap. The main operating unit provides the treatment control circuitry, the primary battery supply, and monitors the operation of the transducer at the fracture site. The signal specifications cannot be changed.

  BIOVENTUS LLC

  2017-01-12

• TalisMann Implant Kit - TM-1000

  BIOVENTUS LLC

  2025-09-01

• StimTrial Surgical Kit - TS-1000

  BIOVENTUS LLC

  2025-09-01

• StimTrial Patient Kit - TS-6000

  BIOVENTUS LLC

  2025-09-01

• StimTrial Stimulator Kit - TS-5000

  BIOVENTUS LLC

  2025-09-01

• Bioventus User Kit - PNS-5000

  BIOVENTUS LLC

  2025-09-01

• Bioventus Clinician Kit - PNS-1000

  BIOVENTUS LLC

  2025-09-01

• SUPARTZ FX sodium hyaluronate - SUPARTZ FX (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ FX is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from chicken combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ FX is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).

  BIOVENTUS LLC

  2023-09-28

• Osteoamp Flowable Access Cannula - The Allograft Delivery Device consists of a cannula and push rod made of biocompatible polypropylene. The device is provided sterile and is intended to be used with hydrated allograft to facilitate delivery into bony defects in orthopedic surgical sites.

  BIOVENTUS LLC

  2024-11-21

• INTERFACE - 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

  2019-05-06

• SIGNAFUSE Bioactive Bone Graft - 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.

  BIOVENTUS LLC

  2020-07-30

• SIGNAFUSE Bioactive Bone Graft - 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.

  BIOVENTUS LLC

  2020-07-30

• SIGNAFUSE Bioactive Bone Graft - 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.

  BIOVENTUS LLC

  2020-07-30

• SIGNAFUSE Bioactive Bone Graft - 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.

  BIOVENTUS LLC

  2020-07-30

• SIGNAFUSE - Bioactive Bone Graft Putty is a synthetic bone void filler comprised of a mixture of calcium phosphate granules (CaP) and (45S5) bioactive glass granules suspended in a resorbable alkyleneoxide polymer (AOP) carrier that facilitates handling and delivery of the granule components. The device is supplied as putty, pre-loaded in a syringe applicator and packaged in a sterile barrier foil pouch. The device is provided sterile, for single use, in a variety of sizes.

  BIOVENTUS LLC

  2019-02-22

• SIGNAFUSE - Bioactive Bone Graft Putty is a synthetic bone void filler comprised of a mixture of calcium phosphate granules (CaP) and (45S5) bioactive glass granules suspended in a resorbable alkyleneoxide polymer (AOP) carrier that facilitates handling and delivery of the granule components. The device is supplied as putty, pre-loaded in a syringe applicator and packaged in a sterile barrier foil pouch. The device is provided sterile, for single use, in a variety of sizes.

  BIOVENTUS LLC

  2019-02-22

• SIGNAFUSE - Bioactive Bone Graft Putty is a synthetic bone void filler comprised of a mixture of calcium phosphate granules (CaP) and (45S5) bioactive glass granules suspended in a resorbable alkyleneoxide polymer (AOP) carrier that facilitates handling and delivery of the granule components. The device is supplied as putty, pre-loaded in a syringe applicator and packaged in a sterile barrier foil pouch. The device is provided sterile, for single use, in a variety of sizes.

  BIOVENTUS LLC

  2019-02-22

• OSTEOFUSE - Bioactive Bone Graft Putty is a synthetic bone void filler comprised of a mixture of calcium phosphate granules (CaP) and (45S5) bioactive glass granules suspended in a resorbable alkyleneoxide polymer (AOP) carrier that facilitates handling and delivery of the granule components. The device is supplied as putty, pre-loaded in a syringe applicator and packaged in a sterile barrier foil pouch. The device is provided sterile, for single use, in a variety of sizes.

  BIOVENTUS LLC

  2019-02-22

• OSTEOFUSE - Bioactive Bone Graft Putty

  BIOVENTUS LLC

  2019-02-22

• OSTEOFUSE - Bioactive Bone Graft Putty

  BIOVENTUS LLC

  2019-02-22

• UNITE Bioactive Bone Graft - Bioactive Bone Graft Putty

  BIOVENTUS LLC

  2019-02-22

• UNITE Bioactive Bone Graft - Bioactive Bone Graft Putty

  BIOVENTUS LLC

  2019-02-22

• UNITE Bioactive Bone Graft - Bioactive Bone Graft Putty

  BIOVENTUS LLC

  2019-02-22

• OSTEOMATRIX+ - OSTEOMATRIX+ is a bone graft substitute comprising biphasic mineral granules 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.

  BIOVENTUS LLC

  2018-12-13

• OSTEOMATRIX+ - OSTEOMATRIX+ is a bone graft substitute comprising biphasic mineral granules 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.

  BIOVENTUS LLC

  2018-12-13

• EXOGEN® Ultrasound Bone Healing System MOU - Replacement Main Operating Unit (MOU) for the EXOGEN Ultrasound Bone Healing System, device identifier M937710344001.

  BIOVENTUS LLC

  2017-01-12

• EXOGEN® Ultrasound Bone Healing System - Replacement MOU for the EXOGEN® Ultrasound Bone Healing System, device identifier M937710346001.

  BIOVENTUS LLC

  2017-01-12

• DUROLANE - DUROLANE is a clear, transparent, viscous gel of highly purified, stabilized, non-animal-derived sodium hyaluronate that is biosynthesized using bacterial fermentation. NASHA® technology is used to stabilize naturally entangled hyaluronic acid (HA) chains to produce a gel. The gel is suspended in phosphate-buffered saline at a concentration of 20 mg/mL. DUROLANE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy or simple analgesics, e.g. acetaminophen.

  BIOVENTUS LLC

  2017-11-20