bioventusglobal.comEXOGEN 3000* LOW INTENSITY FRACTURE HEALING SYSTEM
BIOVENTUS LLC
BIOVENTUS LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009595577 | 3009595577 | BIOVENTUS LLC | 1 | Y | 2026-01-01 | 4721 Emperor Blvd Ste 100 Durham NC US 27703 |
| 3027669735 | 3027669735 | Bioventus LLC | 1 | N | 2026-01-01 | 7101 Goodlett Farms Pkwy Cordova TN US 38016 |
| 3010203571 | 3010203571 | BIOVENTUS LLC | 1 | N | 2020-04-25 | 1900 Charles Bryan Rd Suite 275 Cordova TN US 38016 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00816986020549 | TalisMann Implant Kit - TM-1000 | 888-453-2136 | CustomerServiceUSA@bioventusglobal.com |
| 00816986020570 | StimTrial Patient Kit - TS-6000 | 888-453-2136 | CustomerServiceUSA@bioventusglobal.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 319724 | 1128239693 | P980044 | SUPARTZ FX | MOZ | 2001-01-24 |
| 141198 | 1740796237 | P900009 | SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A | LOF | 1994-10-05 |
| 319724 | 1740796237 | P900009 | SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A | LOF | 1994-10-05 |
| 156900 | 1740796237 | P900009 | SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A | LOF | 1994-10-05 |
| 156900 | 1099201077 | P170007 | DUROLANE | MOZ | 2017-08-29 |
| 141198 | 1099201077 | P170007 | DUROLANE | MOZ | 2017-08-29 |
| 319724 | 1099201077 | P170007 | DUROLANE | MOZ | 2017-08-29 |
| 319724 | 1145824469 | P110005 | SINOVIAL (SODIUM HYALURONATE 0.8%) | MOZ | 2014-05-09 |
| 141198 | 1966010462 | K243782 | StimTrial Neuromodulation System | GZF | 2025-07-16 |
| 319724 | 1966010462 | K243782 | StimTrial Neuromodulation System | GZF | 2025-07-16 |
| 141198 | 1627537570 | K243678 | TalisMann Neuromodulation System | GZF | 2025-07-03 |
| 319724 | 1627537570 | K243678 | TalisMann Neuromodulation System | GZF | 2025-07-03 |
| 141198 | 1885263746 | K233368 | Allograft Delivery Device (OFAC-C) | FMF | 2024-06-25 |
| 141198 | 1800644815 | K211965 | StimRouter Neuromodulation System | GZF | 2022-02-23 |
| 319724 | 1800644815 | K211965 | StimRouter Neuromodulation System | GZF | 2022-02-23 |
| 319724 | 1372610854 | K200482 | StimRouter Neuromodulation System | GZF | 2020-03-27 |
| 141198 | 1372610854 | K200482 | StimRouter Neuromodulation System | GZF | 2020-03-27 |
| 141198 | 1284189927 | K193513 | SIGNAFUSE Bioactive Bone Graft | MQV | 2020-06-18 |
| 319724 | 1422341767 | K190047 | StimRouter Neuromodulation System | GZF | 2019-10-31 |
| 141198 | 1422341767 | K190047 | StimRouter Neuromodulation System | GZF | 2019-10-31 |
| 141198 | 1764229729 | K160446 | MCP Bone Putty | MQV | 2016-11-07 |
| 156900 | 1764229729 | K160446 | MCP Bone Putty | MQV | 2016-11-07 |
| 319724 | 1412909827 | K142432 | StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit | GZF | 2015-02-20 |
| 141198 | 1412909827 | K142432 | StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit | GZF | 2015-02-20 |
| 156900 | 1136636354 | K142276 | MCS Bone Graft | MQV | 2015-01-16 |
| 141198 | 1136636354 | K142276 | MCS Bone Graft | MQV | 2015-01-16 |
| 156900 | 1653449169 | K132071 | BIOACTIVE BONE GRAFT PUTTY | MQV | 2014-01-10 |
| 141198 | 1653449169 | K132071 | BIOACTIVE BONE GRAFT PUTTY | MQV | 2014-01-10 |
| 156900 | 1594219308 | K112857 | INTERFACE BONE VOID FILLER | MQV | 2011-12-13 |
| 141198 | 1594219308 | K112857 | INTERFACE BONE VOID FILLER | MQV | 2011-12-13 |
| 156900 | 1458234646 | K092541 | INTERFACE | MQV | 2010-11-09 |
| 141198 | 1433170706 | K092046 | BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY | MQV | 2010-03-24 |
| 141198 | 2039284591 | BK180252 | |||
| 319724 | 1070359619 | ||||
| 319724 | 1183222936 | ||||
| 319724 | 1356920010 | ||||
| 319724 | 1562762508 | ||||
| 319724 | 1568821522 | ||||
| 319724 | 1572236507 | ||||
| 319724 | 1599493746 | ||||
| 319724 | 1660494541 | ||||
| 319724 | 1672397496 | ||||
| 319724 | 1688078097 | ||||
| 319724 | 1753647481 | ||||
| 319724 | 1777117858 | ||||
| 319724 | 1835119099 | ||||
| 319724 | 1966308235 | ||||
| 319724 | 2005046627 |
Product Codes Associated With Registrations#
PMA#
EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM
BIOVENTUS LLC
EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM
BIOVENTUS LLC
EXOGEN 2000+(TM) SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R))
BIOVENTUS LLC
EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM
BIOVENTUS LLC
EXOGEN 2000/SONIC ACCELERATED FRACTURE HEALING SYSTEM
BIOVENTUS LLC
SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) MODEL 2000, EXOGEN 2000
BIOVENTUS LLC
SONIC ACCELERATED FRACTURE HEALING SYSTEM/EXOGEN 3000 (TM)
BIOVENTUS LLC
EXOGEN 3000
BIOVENTUS LLC
SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2000
BIOVENTUS LLC
SONIC ACCELERATED FRACTURE HEALING SYSTEM
BIOVENTUS LLC
SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2000
BIOVENTUS LLC
SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
BIOVENTUS LLC
SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
BIOVENTUS LLC
SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
BIOVENTUS LLC
PMN#
MCS Bone Graft
BIOVENTUS LLC
GUDID#
EXOGEN Metatarsal Strap - 71034660
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.
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.
2017-01-12
TalisMann Implant Kit - TM-1000
2025-09-01
StimTrial Surgical Kit - TS-1000
2025-09-01
StimTrial Patient Kit - TS-6000
2025-09-01
StimTrial Stimulator Kit - TS-5000
2025-09-01
Bioventus User Kit - PNS-5000
2025-09-01
Bioventus Clinician Kit - PNS-1000
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
2019-02-22
OSTEOFUSE - Bioactive Bone Graft Putty
2019-02-22
OSTEOFUSE - Bioactive Bone Graft Putty
2019-02-22
UNITE Bioactive Bone Graft - Bioactive Bone Graft Putty
2019-02-22
UNITE Bioactive Bone Graft - Bioactive Bone Graft Putty
2019-02-22
UNITE Bioactive Bone Graft - Bioactive Bone Graft Putty
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.
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.
2018-12-13
EXOGEN® Ultrasound Bone Healing System MOU - Replacement Main Operating Unit (MOU) for the EXOGEN Ultrasound Bone Healing System, device identifier M937710344001.
2017-01-12
EXOGEN® Ultrasound Bone Healing System - Replacement MOU for the EXOGEN® Ultrasound Bone Healing System, device identifier M937710346001.
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.
2017-11-20