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

Company510(k)sRecalls
Regeneration Technologies, Inc.527
Skeletal Kinetics, LLC624
Wrightmedicaltechnologyinc280
Novabone Products, LLC190
Medtronic Sofamor Danek161
Berkeley Advanced Biomaterials141
Etex Corp.140
Musculoskeletal Transplant Foundation95
Biocomposites, Ltd.111
Kuros Biosciences120
DateFirm and productCodeLinked 510(k)
Feb 7, 2006Regeneration Technologies, Inc.
Product is OPTEFORM Allograft Full Disc, 5 x 90mm, 32cc, Frozen. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated		 MQVK043420
Feb 7, 2006Regeneration Technologies, Inc.
Product is OPTEFIL Allograft Paste, Syringe of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated		 MQVK043420
Feb 7, 2006Regeneration Technologies, Inc.
Product is OPTEFIL Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated		 MQVK043420
Feb 7, 2006Regeneration Technologies, Inc.
Product is 1.0cc flowable paste from donor approved for distribution in Italy. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT U
Terminated		 MQVK043420
Feb 7, 2006Regeneration Technologies, Inc.
Product is REGENAFIL Allograft Paste, Syringe, 0.5cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated		 MQVK043420
Feb 7, 2006Regeneration Technologies, Inc.
Product is RTI Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated		 MQVK043421
Feb 7, 2006Regeneration Technologies, Inc.
Product is REGENAFORM Allograft Moldable Blocks, of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated		 MQVK043420
Feb 7, 2006Regeneration Technologies, Inc.
Product is REGENAFORM RT Allograft Paste, 1cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated		 MQVK043420
Feb 7, 2006Regeneration Technologies, Inc.
Product is Regenafil IC. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated		 MQVK043420
Feb 7, 2006Regeneration Technologies, Inc.
OsteoPack 3 FZ 22cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated		 MQVK043420
Feb 7, 2006Regeneration Technologies, Inc.
OSTEOFIL DBM Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated		 MQVK043420
Feb 7, 2006Regeneration Technologies, Inc.
Osteofil RT, ICM Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated		 MQVK043421
Feb 7, 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		 MQVK043421
Feb 7, 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		 MQVK043420
Feb 7, 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
Feb 7, 2006Regeneration Technologies, Inc.
Osteofil + RT Allograft Paste in varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated		 MQVK043421
Feb 7, 2006Regeneration Technologies, Inc.
OPTEFORM RT Moldable Allograft of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated		 MQVK043421
Feb 7, 2006Regeneration Technologies, Inc.
Product is OPTEFORM Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated		 MQVK043421
Feb 7, 2006Regeneration Technologies, Inc.
Product is OPTEFORM Allografts of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated		 MQVK043421
Feb 7, 2006Regeneration Technologies, Inc.
Product is 1.0 cc Regenaform RT. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Terminated		 MQVK043420

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