Bioventus L L C

FDA Filings

This page includes the latest FDA filings for Bioventus L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010203571
• FEI Number: 3010203571
• Name: BIOVENTUS LLC
• Owner & Operator: Bioventus LLC
• Contact Address: 4721 Emperor Blvd., Suite 100 ; Durham NC 27703 US
• Official Correspondent:
  • Kim P Kelly
  • x-919-4746704-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1900 Charles Bryan Rd Suite 275 ; Cordova, TN 38016 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3009595577
• FEI Number: 3009595577
• Name: BIOVENTUS LLC
• Owner & Operator: Bioventus LLC
• Contact Address: 4721 Emperor Blvd., Suite 100 ; Durham NC 27703 US
• Official Correspondent:
  • Kim P Kelly
  • x-919-4746704-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 4721 Emperor Blvd Ste 100 ; Durham, NC 27703 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GUDID 10389130444418 BIOVENTUS LLC	SUPARTZ FX sodium hyaluronate	2023-10-06
PMA P170007S011 Bioventus LLC	DUROLANE	2022-01-25
PMA P900009S048 BIOVENTUS LLC	Exogen	2022-01-07
GUDID M937710346601 BIOVENTUS LLC	EXOGEN Metatarsal Strap	2021-12-27
PMA P170007S010 Bioventus LLC	DUROLANE	2021-12-22
PMA P900009S047 BIOVENTUS LLC	EXOGEN Ultrasound Bone Healing System	2021-08-31
PMA P170007S009 Bioventus LLC	DUROLANE	2021-05-25
PMA P900009S046 BIOVENTUS LLC	EXOGEN Ultrasound Bone Healing System	2021-04-14
PMA P170007S007 Bioventus LLC	DUROLANE	2020-11-29
PMA P170007S008 Bioventus LLC	DUROLANE	2020-10-21
PMA P170007S006 Bioventus LLC	DUROLANE	2020-10-08
GUDID 00816986020518 BIOVENTUS LLC	SIGNAFUSE Bioactive Bone Graft SGFS-040	2020-08-07
GUDID 00816986020501 BIOVENTUS LLC	SIGNAFUSE Bioactive Bone Graft SGFS-020	2020-08-07
GUDID 00816986020495 BIOVENTUS LLC	SIGNAFUSE Bioactive Bone Graft SGFS-010	2020-08-07
GUDID 00816986020488 BIOVENTUS LLC	SIGNAFUSE Bioactive Bone Graft SGFS-005	2020-08-07
GUDID 00816986020082 BIOVENTUS LLC	OSTEOFUSE OF001	2020-03-20
GUDID 00816986020020 BIOVENTUS LLC	SIGNAFUSE SGF-037	2020-03-20
GUDID 00816986020013 BIOVENTUS LLC	SIGNAFUSE SGF-075	2020-03-20
GUDID 00816986020006 BIOVENTUS LLC	SIGNAFUSE SGF-150	2020-03-20
GUDID M937710344001 BIOVENTUS LLC	EXOGEN® Ultrasound Bone Healing System 71034400	2020-02-06
PMA P900009S044 BIOVENTUS LLC	Exogen Ultrasound Bone Healing System	2019-12-20
PMA P170007S005 Bioventus LLC	Durolane, Hyaluronic Acid, Stabilized Single Injection	2019-12-18
GUDID M937710346001 BIOVENTUS LLC	EXOGEN® Ultrasound Bone Healing System 71034600	2019-12-11
PMA P170007S004 Bioventus LLC	Durolane	2019-09-19
PMA P170007S003 Bioventus LLC	Durolane, Hyaluronic Acid, Stabilized Single Injection	2019-06-08
GUDID 00816986020037 BIOVENTUS LLC	INTERFACE IFBG100	2019-05-14
PMA P170007S002 Bioventus LLC	DUROLANE	2019-03-13
GUDID 00816986020150 BIOVENTUS LLC	UNITE Bioactive Bone Graft MSBG1500	2019-03-11
GUDID 00816986020143 BIOVENTUS LLC	UNITE Bioactive Bone Graft MSBG0750	2019-03-11
GUDID 00816986020136 BIOVENTUS LLC	UNITE Bioactive Bone Graft MSBG0375	2019-03-11
GUDID 00816986020105 BIOVENTUS LLC	OSTEOFUSE OF003	2019-03-11
GUDID 00816986020099 BIOVENTUS LLC	OSTEOFUSE OF002	2019-03-11
GUDID 00816986020129 BIOVENTUS LLC	OSTEOMATRIX+ OMP-18	2019-01-14
GUDID 00816986020112 BIOVENTUS LLC	OSTEOMATRIX+ OMP-09	2019-01-14
PMN K160446 | MQV BIOVENTUS LLC	OSTEOMATRIX+	2018-12-11
PMN K160446 | MQV BIOVENTUS LLC	OSTEOMATRIX+	2018-12-11
PMA P170007S001 Bioventus LLC	DUROLOANE	2018-08-17
GUDID 00816986020808 BIOVENTUS LLC	DUROLANE 1082020	2018-07-06
PMA P900009S043 BIOVENTUS LLC	EXOGEN Ultrasound Bone Healing System	2018-05-22
PMN P170007 | MOZ BIOVENTUS LLC	DUROLANE	2017-10-23
PMA P900009S042 BIOVENTUS LLC	EXOGEN Ultrasound Bone Healing System	2017-09-11
PMA P170007 Bioventus LLC	DUROLANE	2017-08-29
PMN K162860 BIOVENTUS LLC	MCS Bone Graft	2017-02-13
PMA P900009S041 BIOVENTUS LLC	EXOGEN ULTRASOUND BONE HEALING SYSTEM	2017-01-12
PMN K142276 | MQV BIOVENTUS LLC	Silhouettte	2016-04-07
PMN K142276 | MQV BIOVENTUS LLC	Silhouettte	2016-04-07
PMN K132071 | MQV BIOVENTUS LLC	Unite	2016-04-07
PMN K132071 | MQV BIOVENTUS LLC	Unite	2016-04-07
PMN K132071 | MQV BIOVENTUS LLC	Signafuse	2016-04-07
PMN K132071 | MQV BIOVENTUS LLC	Signafuse	2016-04-07
PMN K132071 | MQV BIOVENTUS LLC	Osteofuse	2016-04-07
PMN K132071 | MQV BIOVENTUS LLC	Osteofuse	2016-04-07
PMN K112857 | MQV BIOVENTUS LLC	Interface	2016-04-07
PMN K112857 | MQV BIOVENTUS LLC	Interface	2016-04-07
PMN K092541 | MQV BIOVENTUS LLC	Interface	2016-04-07
PMN K092046 | MQV BIOVENTUS LLC	OsteoMatrix	2016-04-07
PMA P900009S039 BIOVENTUS LLC	EXOGEN ULTRASOUND BONE HEALING SYSTEM	2015-04-22
PMA P900009S038 BIOVENTUS LLC	EXOGEN ULTRASOUND BONE HEALING SYSTEM	2014-12-08
PMA P900009S037 BIOVENTUS LLC	EXOGEN ULTRASOUND BONE HEALING SYSTEM	2014-08-21
PMA P900009S035 BIOVENTUS LLC	EXOGEN ULTRASOUND BONE HEALING SYSTEM	2014-05-29
PMA P900009S036 BIOVENTUS LLC	EXOGEN ULTRASOUND BONE HEALING SYSTEM	2014-05-07
PMA P900009S033 BIOVENTUS LLC	ULTRASOUND BONE HEALING SYSTEM	2012-06-06
PMN P900009 | LPQ BIOVENTUS LLC	SAFHS	2012-05-04
PMN P900009 | LPQ BIOVENTUS LLC	SAFHS	2012-05-04
PMN P900009 | LPQ BIOVENTUS LLC	EXOGEN	2012-05-04
PMN P900009 | LPQ BIOVENTUS LLC	EXOGEN	2012-05-04
PMN P900009 | LPQ BIOVENTUS LLC	EXOGEN EXPRESS	2012-05-04
PMN P900009 | LPQ BIOVENTUS LLC	EXOGEN EXPRESS	2012-05-04
PMN P900009 | LPQ BIOVENTUS LLC	EXOGEN 4000J	2012-05-04
PMN P900009 | LPQ BIOVENTUS LLC	EXOGEN 4000J	2012-05-04
PMN P900009 | LOF BIOVENTUS LLC	SAFHS	2012-05-04
PMN P900009 | LOF BIOVENTUS LLC	SAFHS	2012-05-04
PMN P900009 | LOF BIOVENTUS LLC	EXOGEN	2012-05-04
PMN P900009 | LOF BIOVENTUS LLC	EXOGEN	2012-05-04
PMN P900009 | LOF BIOVENTUS LLC	EXOGEN EXPRESS	2012-05-04
PMN P900009 | LOF BIOVENTUS LLC	EXOGEN EXPRESS	2012-05-04
PMN P900009 | LOF BIOVENTUS LLC	EXOGEN 4000J	2012-05-04
PMN P900009 | LOF BIOVENTUS LLC	EXOGEN 4000J	2012-05-04
PMA P900009S032 BIOVENTUS LLC	EXOGEN 4000+	2010-03-26
PMA P900009S031 BIOVENTUS LLC	EXOGEN BONE HEALING SYSTEM	2009-10-02
PMA P900009S030 BIOVENTUS LLC	EXOGEN 4000+ BONE HEALING SYSTEM	2009-03-13
PMA P900009S021 BIOVENTUS LLC	EXOGEN BONE HEALING SYSTEM 2000 ,3000	2008-12-19
PMA P900009S029 BIOVENTUS LLC	EXOGEN 4000+BONE HEALING SYSTEM	2008-12-18
PMA P900009S028 BIOVENTUS LLC	EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)	2007-08-16
PMA P900009S027 BIOVENTUS LLC	EXOGEN 4000+BONE HEALING SYSTEM	2007-08-16
PMA P900009S025 BIOVENTUS LLC	EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)	2007-06-11
PMA P900009S024 BIOVENTUS LLC	EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)	2006-11-01
PMA P900009S023 BIOVENTUS LLC	EXOGEN 2000+ BONE HEALING SYSTEM	2006-06-30
PMA P900009S022 BIOVENTUS LLC	EXOGEN 4000+ BONE HEALING SYSTEM	2006-06-26
PMA P900009S020 BIOVENTUS LLC	EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) AND EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM	2005-05-19
PMA P900009S019 BIOVENTUS LLC	EXOGEN 2000+	2004-05-07
PMA P900009S018 BIOVENTUS LLC	EXOGEN 2000+ AND EXOGEN 3000	2004-03-12
PMA P900009S017 BIOVENTUS LLC	EXOGEN 2000+ LOW INTENSITY FRACTURE HEALING SYSTEM	2003-04-22
PMA P900009S016 BIOVENTUS LLC	EXOGEN 3000* LOW INTENSITY FRACTURE HEALING SYSTEM	2003-02-21
PMA P900009S014 BIOVENTUS LLC	EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM	2002-11-18
PMA P900009S015 BIOVENTUS LLC	EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM	2002-03-29
PMA P900009S013 BIOVENTUS LLC	EXOGEN 2000+(TM) SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R))	2001-09-04
PMA P900009S012 BIOVENTUS LLC	EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM	2001-02-21
PMA P900009S011 BIOVENTUS LLC	EXOGEN 2000/SONIC ACCELERATED FRACTURE HEALING SYSTEM	2000-09-08
PMA P900009S009 BIOVENTUS LLC	SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) MODEL 2000, EXOGEN 2000	2000-06-22
PMA P900009S010 BIOVENTUS LLC	SONIC ACCELERATED FRACTURE HEALING SYSTEM/EXOGEN 3000 (TM)	2000-05-10
PMA P900009S008 BIOVENTUS LLC	EXOGEN 3000	2000-04-14
PMA P900009S006 BIOVENTUS LLC	SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2000	2000-02-22
PMA P900009S007 BIOVENTUS LLC	SONIC ACCELERATED FRACTURE HEALING SYSTEM	1999-08-25
PMA P900009S003 BIOVENTUS LLC	SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2000	1997-03-27
PMA P900009S002 BIOVENTUS LLC	SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A	1996-04-02
PMA P900009S001 BIOVENTUS LLC	SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A	1995-07-07
PMA P900009 BIOVENTUS LLC	SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A	1994-10-05

Similar & Related FDA Registered Companies

• 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 - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• 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 - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• 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 - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	78N94	BIOVENTUS LLC!DBA OSTEOAMP
CAGE Code	78N94	BIOVENTUS LLC OSTEOAMP
S.A.M. Registration	78N94 [78450878]	BIOVENTUS LLC OSTEOAMP

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092555454	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	382 CTN
2020092555454	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	382 CTN
2020083130936	Genova,Italy -> Savannah, Georgia	(ON 8 SKIDS) MEDICAL DEVICES GELSYN-3 2ML - 1 SYRINGE SET TEMPERATURE 20 CEL HS-CODE 30049000	362 CTN
2020081222281	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	381 CTN
2020081222281	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	381 CTN
2020081034168	Genova,Italy -> Savannah, Georgia	(ON 12 SKIDS) MEDICAL DEVICES GELSYN-3 2ML - 1 SYRINGE SET TEMPERATURE 20 CEL HS-CODE(S) 30049000 HS-CODE 30049000	544 BOX
2020080830367	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	381 CTN
2020080830367	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	381 CTN
2020080143262	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	381 CTN
2020080143262	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	381 CTN
2020072452907	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	381 CTN
2020072452907	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	381 CTN
2020072020634	Genova,Italy -> Savannah, Georgia	(ON 16 SKIDS) MEDICAL DEVICES GELSYN-3 2ML - 1 SYRINGE SET TEMPERATURE 20 CEL HS-CODE 30049000	718 PKG