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BIOVENTUS LLC

Matched from indexed company URL: Bioventus, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30095955773009595577BIOVENTUS LLC1Y2026-01-014721 Emperor Blvd Ste 100 Durham NC US 27703
30276697353027669735Bioventus LLC1N2026-01-017101 Goodlett Farms Pkwy Cordova TN US 38016
30102035713010203571BIOVENTUS LLC1N2020-04-251900 Charles Bryan Rd Suite 275 Cordova TN US 38016

GUDID Contact Samples#

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

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00816986020549TalisMann Implant Kit - TM-1000888-453-2136CustomerServiceUSA@bioventusglobal.com
00816986020570StimTrial Patient Kit - TS-6000888-453-2136CustomerServiceUSA@bioventusglobal.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3197241128239693P980044SUPARTZ FXMOZ2001-01-24
1411981740796237P900009SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2ALOF1994-10-05
1569001740796237P900009SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2ALOF1994-10-05
3197241740796237P900009SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2ALOF1994-10-05
1569001099201077P170007DUROLANEMOZ2017-08-29
1411981099201077P170007DUROLANEMOZ2017-08-29
3197241099201077P170007DUROLANEMOZ2017-08-29
3197241145824469P110005SINOVIAL (SODIUM HYALURONATE 0.8%)MOZ2014-05-09
1411981966010462K243782StimTrial Neuromodulation SystemGZF2025-07-16
3197241966010462K243782StimTrial Neuromodulation SystemGZF2025-07-16
3197241627537570K243678TalisMann Neuromodulation SystemGZF2025-07-03
1411981627537570K243678TalisMann Neuromodulation SystemGZF2025-07-03
1411981885263746K233368Allograft Delivery Device (OFAC-C)FMF2024-06-25
1411981800644815K211965StimRouter Neuromodulation SystemGZF2022-02-23
3197241800644815K211965StimRouter Neuromodulation SystemGZF2022-02-23
1411981372610854K200482StimRouter Neuromodulation SystemGZF2020-03-27
3197241372610854K200482StimRouter Neuromodulation SystemGZF2020-03-27
1411981284189927K193513SIGNAFUSE Bioactive Bone GraftMQV2020-06-18
1411981422341767K190047StimRouter Neuromodulation SystemGZF2019-10-31
3197241422341767K190047StimRouter Neuromodulation SystemGZF2019-10-31
1569001764229729K160446MCP Bone PuttyMQV2016-11-07
1411981764229729K160446MCP Bone PuttyMQV2016-11-07
3197241412909827K142432StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User KitGZF2015-02-20
1411981412909827K142432StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User KitGZF2015-02-20
1569001136636354K142276MCS Bone GraftMQV2015-01-16
1411981136636354K142276MCS Bone GraftMQV2015-01-16
1569001653449169K132071BIOACTIVE BONE GRAFT PUTTYMQV2014-01-10
1411981653449169K132071BIOACTIVE BONE GRAFT PUTTYMQV2014-01-10
1569001594219308K112857INTERFACE BONE VOID FILLERMQV2011-12-13
1411981594219308K112857INTERFACE BONE VOID FILLERMQV2011-12-13
1569001458234646K092541INTERFACEMQV2010-11-09
1411981433170706K092046BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTYMQV2010-03-24
1411982039284591BK180252
3197241070359619
3197241183222936
3197241356920010
3197241562762508
3197241568821522
3197241572236507
3197241599493746
3197241660494541
3197241672397496
3197241688078097
3197241753647481
3197241777117858
3197241835119099
3197241966308235
3197242005046627

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GZF122025-07-16
MQV112020-06-18
MOZ52017-08-29
LOF31994-10-05
FMF12024-06-25

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 -...

58 records. Showing 1-40. Next

PMN#

GUDID#

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

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

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 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

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