ClearanceBrief
510(k) K043421 ยท MQV Filler, Bone Void, Calcium Compound

OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC

ApplicantRegeneration Technologies, Inc., Alachua FL, US
DecisionSubstantially Equivalent, Feb 16, 2005
ReceivedDec 13, 2004
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K043421

DateFirm and productCodeLinked 510(k)
Apr 26, 2019Exactech, Inc.
Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
Terminated		 MQVNone listed
Apr 26, 2019Exactech, Inc.
Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
Terminated		 MQVNone listed
Apr 26, 2019Exactech, Inc.
Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
Terminated		 MQVNone listed
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		 MQVNone listed
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		 MQVNone listed
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		 MQVNone listed
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		 MQVNone listed
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		 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		 MQVNone listed
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		 MQVNone listed
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		 MQVNone listed
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		 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		 MQVNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.