ClearanceBrief
Panels › Orthopedic › Product code MQV · Class 2

Filler, Bone Void, Calcium Compound

Regulation 888.3045

5510(k)s in 12 months (493 all time)
5recalls in 12 months (120 all time)
103recalls that name a 510(k)
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Top companies in MQV

DateFirm and productCodeLinked 510(k)
Apr 26, 2019Exactech, Inc.
Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
Terminated
MQVK043421
Apr 26, 2019Exactech, Inc.
Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
Terminated
MQVK043421
Feb 13, 2019Bioventus, LLC
BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Sold under the brand names
Terminated
MQVK132071
Nov 15, 2018Howmedica Osteonics Corp.
HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE
Terminated
MQVK161447
Nov 15, 2018Howmedica Osteonics Corp.
HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
Terminated
MQVK161447
Aug 10, 2017Synthes USA
Norian Drillable Inject
Terminated
MQVK073303
Jan 23, 2017RTI Surgical, Inc.
RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
Terminated
MQVK043421
Dec 5, 2016Acumed LLC
OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt.
Terminated
MQVK042340
Jun 9, 2016Synthes (USA) Products LLC
Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.
Terminated
MQVK073303
K102722
Jun 9, 2016Synthes (USA) Products LLC
Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.
Terminated
MQVK073303
K102722
Jun 9, 2016Synthes (USA) Products LLC
Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S Intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure.
Terminated
MQVK102722
Aug 18, 2015Apatech Limited
Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.
Terminated
MQVK071206
K081979 +2
Jul 24, 2015Skeletal Kinetics, Llc
InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler. Sterilized using irradiation. The single-use InjectionPlasty 1.0 Kit contains the necessary
Terminated
MQVK051123
Apr 17, 2015Musculoskeletal Transplant Foundation, Inc.
DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.
Terminated
MQVK040262
May 6, 2014AlloSource, Inc.
AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is i
Terminated
MQVK071849
Feb 7, 2014RTI Surgical, Inc.
***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th Co
Terminated
MQVK043421
Oct 31, 2013Globus Medical, Inc.
Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Micro
Terminated
MQVK102392
Jan 7, 2013Surgical Tissue Network, Inc.
UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 10cc Product Code: RT53010 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATION
Terminated
MQVNone listed
Jan 7, 2013Surgical Tissue Network, Inc.
UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 5cc Product Code: RT53005 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL
Terminated
MQVNone listed
Jan 7, 2013Surgical Tissue Network, Inc.
Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Product Code: RT53001 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE
Terminated
MQVNone listed
Jun 12, 2012Integra LifeSciences Corp.
Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (IP3-Tricalcium phosphate) matrix in putty and strip forms. T
Terminated
MQVK062353
Jun 12, 2012Integra LifeSciences Corp.
Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-Tricalcium phosphate) matrix in putty and strip forms. The product is
Terminated
MQVK063124
Feb 8, 2012Integra LifeSciences Corp
Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty, combined with bone marrow aspirate, is intended for use as a bone void filler to fill voids or gaps of the skeletal syste
Terminated
MQVK062353
Jan 11, 2012Synthes USA
SRS FAST SET PUTTY 3 CC BONE VOID FILLER-STERILE, Part Number SRS-005-FSP, Lot number N001101. Bone void filler.
Terminated
MQVK060408
Dec 2, 2011Nanotherapeutics, Inc
Product is labeled in part - Pouch label: "***NanoFUSE***DBM***Manufactured and Distributed By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua, FL 32615 (386) 462-9663***Description:
Terminated
MQVK110976
Dec 2, 2011Nanotherapeutics, Inc
Product is labeled in part - Pouch label: "***ORTHOFIX***Manufactured By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua, FL 32615 (386) 462-9663***Description: Origen***DBM Paste**
Terminated
MQVK110976
Jun 23, 2011RTI Biologics, Inc.
***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, FL, USA 32615***Distributed by: SpinalGraft Technologies, LLC 4340 Swinnea Road STE 39 Memphis, TN 38118***OSTEOFIL DBM Paste, 5cc Tissue ID
Terminated
MQVK043420
Mar 16, 2011Biostructures, LLC
OSTEOMATRIX bone graft substitute. OMG10. Osteomatrix is provided sterile for single patient use.
Terminated
MQVK063527
Sep 3, 2009Theken Spine LLC
iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010, Exp. 2010-04.
Terminated
MQVK040134
Mar 6, 2009Integra LifeSciences Corp
Integra Mosaik Putty, 15cc, Catalog # PTY10256 Integra Lifesciences, Plainsboro, NJ
Terminated
MQVK062353
Sep 18, 2008Theken Spine LLC
FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in a box following sterilization. Part # 50-07-0100 Is a flowable resorbable porous bone void filler composed o
Terminated
MQVK053228
Sep 17, 2008Michigan Orthopaedic Products, Inc.
InterGro DBM Demineralized Bone Matrix in a lipid carrier; Provided by: Lifelink Tissue Bank, Tampa, Florida, EBI A Biomet Company, Parsippany, New Jersey; REF DBM002. InterGro DBM product contain hu
Terminated
MQVNone listed
Mar 26, 2008LifeCell Corporation
AlloCraft DBM with Syringe Assembly, 10 CC, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine
Terminated
MQVK052735
Mar 26, 2008LifeCell Corporation
AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine
Terminated
MQVK052735
Feb 14, 2008EBI, L.P.
OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm., Catalog Number: 45-5537 and Catalog Number : LGAL906, Distributed by EBI. (dba Biomet Spine, Biomet Trauma, Biomet Br
Terminated
MQVNone listed
Feb 14, 2008Interpore Cross International Inc
Allogenix; DBM in a Lipid Carrier with Calcium Granules; Model Numbers: 02-3110, Interpore Cross International, a Biomet company (Allogenix DBM products contain human tissue (allograft bone) and are
Terminated
MQVNone listed
Feb 14, 2008Interpore Cross International Inc
InterGro PLUS; DBM in a Lipid Carrier with Calcium Granules; Model Numbers: DBM002, DBM005, DBM010, DBMW05 & DBMW10, Interpore Cross International, a Biomet company (lnterGro DBM products contain hu
Terminated
MQVK031399
Feb 22, 2007Teknimed SA
OsSatura TCP (pure tricalcium phosphate) 3mm granules packaged in glass jars, Part Numbers: 05-6010-050 5cc, 05-6010-100 10cc, 05-6010-150 15cc & 05-6010-300 30cc
Terminated
MQVK031826
Dec 30, 2006Smith & Nephew, Inc. Endoscopy Division
TruFit BGS Plug Size Code Blue, 9mm; quantity 1; Part #600-001-05; product labeled as sterile; manufactured by OsteoBiologics, Inc., San Antonio, TX.
Terminated
MQVNone listed
Dec 30, 2006Smith & Nephew, Inc. Endoscopy Division
TruFit BGS Plug Size Code Red, 7mm; quantity 1; Part #600-001-03; product labeled as sterile; manufactured by OsteoBiologics, Inc., San Antonio, TX.
Terminated
MQVNone listed
Dec 30, 2006Smith & Nephew, Inc. Endoscopy Division
TruFit CB Plug Size Code Blue, 9mm; quantity 1; Part #605-001-05; product labeled as sterile; manufactured by OsteoBiologics, Inc., San Antonio, TX.
Terminated
MQVNone listed
Dec 30, 2006Smith & Nephew, Inc. Endoscopy Division
TruFit CB Plug Size Code Red, 7mm; quantity 1; Part #605-001-03; product labeled as sterile; manufactured by OsteoBiologics, Inc., San Antonio, TX.
Terminated
MQVK040047
Dec 14, 2006Stryker Biotech
Calstrux (Previously known as TCP Putty)- Absorbable Bone Void Filler, packaged in: Catalog Number: 400-05: quantity-5cc Catalog Number: 400-10: quantity 10cc Catalog Number: 400-15: quantity 15cc
Terminated
MQVK041421
Mar 28, 2006Regeneration Technologies, Inc.
Osteofil RT, ICM Allograft Paste in varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated
MQVNone listed
Mar 28, 2006Regeneration Technologies, Inc.
Osteofil ICM Moldable Strip of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated
MQVNone listed
Mar 28, 2006Regeneration Technologies, Inc.
Osteofil IC Syringeable of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated
MQVNone listed
Mar 28, 2006Regeneration Technologies, Inc.
Osteofil Allograft Paste (Bio) of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated
MQVNone listed
Mar 28, 2006Regeneration Technologies, Inc.
Osteofil Allograft, 5cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated
MQVNone listed
Mar 28, 2006Regeneration Technologies, Inc.
Osteofil + RT Allograft Paste 10cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated
MQVNone listed
Feb 7, 2006Regeneration Technologies, Inc.
Product is 2.0 cc Opteform RT. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated
MQVK043421

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