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)
Top companies in MQV
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2019 | Exactech, Inc. Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45 Terminated |
MQV | K043421 |
| Apr 26, 2019 | Exactech, Inc. Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30 Terminated |
MQV | K043421 |
| Feb 13, 2019 | Bioventus, 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 |
MQV | K132071 |
| Nov 15, 2018 | Howmedica Osteonics Corp. HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE Terminated |
MQV | K161447 |
| Nov 15, 2018 | Howmedica Osteonics Corp. HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE Terminated |
MQV | K161447 |
| Aug 10, 2017 | Synthes USA Norian Drillable Inject Terminated |
MQV | K073303 |
| Jan 23, 2017 | RTI Surgical, Inc. RTI Biologics BioSet IC RT Paste 2 cc
Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications Terminated |
MQV | K043421 |
| Dec 5, 2016 | Acumed 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 |
MQV | K042340 |
| Jun 9, 2016 | Synthes (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 |
MQV | K073303 K102722 |
| Jun 9, 2016 | Synthes (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 |
MQV | K073303 K102722 |
| Jun 9, 2016 | Synthes (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 |
MQV | K102722 |
| Aug 18, 2015 | Apatech 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 |
MQV | K071206 K081979 +2 |
| Jul 24, 2015 | Skeletal 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 |
MQV | K051123 |
| Apr 17, 2015 | Musculoskeletal Transplant Foundation, Inc. DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler. Terminated |
MQV | K040262 |
| May 6, 2014 | AlloSource, 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 |
MQV | K071849 |
| Feb 7, 2014 | RTI 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 |
MQV | K043421 |
| Oct 31, 2013 | Globus 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 |
MQV | K102392 |
| Jan 7, 2013 | Surgical 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 |
MQV | None listed |
| Jan 7, 2013 | Surgical 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 |
MQV | None listed |
| Jan 7, 2013 | Surgical 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 |
MQV | None listed |
| Jun 12, 2012 | Integra 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 |
MQV | K062353 |
| Jun 12, 2012 | Integra 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 |
MQV | K063124 |
| Feb 8, 2012 | Integra 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 |
MQV | K062353 |
| Jan 11, 2012 | Synthes USA SRS FAST SET PUTTY 3 CC BONE VOID FILLER-STERILE, Part Number SRS-005-FSP, Lot number N001101.
Bone void filler. Terminated |
MQV | K060408 |
| Dec 2, 2011 | Nanotherapeutics, 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 |
MQV | K110976 |
| Dec 2, 2011 | Nanotherapeutics, 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 |
MQV | K110976 |
| Jun 23, 2011 | RTI 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 |
MQV | K043420 |
| Mar 16, 2011 | Biostructures, LLC OSTEOMATRIX bone graft substitute. OMG10.
Osteomatrix is provided sterile for single
patient use. Terminated |
MQV | K063527 |
| Sep 3, 2009 | Theken 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 |
MQV | K040134 |
| Mar 6, 2009 | Integra LifeSciences Corp Integra Mosaik Putty, 15cc, Catalog # PTY10256
Integra Lifesciences, Plainsboro, NJ Terminated |
MQV | K062353 |
| Sep 18, 2008 | Theken 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 |
MQV | K053228 |
| Sep 17, 2008 | Michigan 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 |
MQV | None listed |
| Mar 26, 2008 | LifeCell Corporation AlloCraft DBM with Syringe Assembly, 10 CC, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine Terminated |
MQV | K052735 |
| Mar 26, 2008 | LifeCell Corporation AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine Terminated |
MQV | K052735 |
| Feb 14, 2008 | EBI, 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 |
MQV | None listed |
| Feb 14, 2008 | Interpore 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 |
MQV | None listed |
| Feb 14, 2008 | Interpore 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 |
MQV | K031399 |
| Feb 22, 2007 | Teknimed 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 |
MQV | K031826 |
| Dec 30, 2006 | Smith & 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 |
MQV | None listed |
| Dec 30, 2006 | Smith & 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 |
MQV | None listed |
| Dec 30, 2006 | Smith & 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 |
MQV | None listed |
| Dec 30, 2006 | Smith & 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 |
MQV | K040047 |
| Dec 14, 2006 | Stryker 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 |
MQV | K041421 |
| Mar 28, 2006 | Regeneration 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 |
MQV | None listed |
| Mar 28, 2006 | Regeneration 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 |
MQV | None listed |
| Mar 28, 2006 | Regeneration 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 |
MQV | None listed |
| Mar 28, 2006 | Regeneration 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 |
MQV | None listed |
| Mar 28, 2006 | Regeneration Technologies, Inc. Osteofil Allograft, 5cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''. Terminated |
MQV | None listed |
| Mar 28, 2006 | Regeneration 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 |
MQV | None listed |
| Feb 7, 2006 | Regeneration 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 |
MQV | K043421 |
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