FDA 510(k) Applications for Medical Device Product Code "NUN"
(Bone Grafting Material, Human Source)

FDA 510(k) Number Applicant Device Name Decision Date
K070147 BIOMET 3I INTERGRO ORAL 05/14/2007
K113645 BIOMET INTERPORE CROSS REGENEROSS ALLOGRAFT PLUS MINERLIZED 01/20/2012
K103699 EXACTECH, INC. EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC 08/12/2011
K130235 HANS BIOMED CORP. SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY 01/10/2014
K060306 ISOTIS NV ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY 03/27/2006
K060332 ISOTIS NV ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY 03/29/2006
K043573 ISOTIS ORTHOBIOLOGICS, INC DYNAGRAFT II DENTAL 07/29/2005
K082463 MEDTRONIC SOFAMOR DANEK PROGENIX 11/10/2008
K080462 MEDTRONIC SOFAMOR DANEK PROGENIX DBM PUTTY 05/13/2008
K081950 MEDTRONIC SOFAMOR DANEK, INC. PROGENIX PLUS 07/18/2008
K091217 MUSCULOSKELETAL TRANSPLANT FOUNDATION DBX DEMINERALIZED BONE MATRIX PUTTY 10/02/2009
K040501 MUSCULOSKELETAL TRANSPLANT FOUNDATION DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX 04/29/2005
K051188 OSTEOTECH, INC. GRAFTON DBM 01/03/2006
K042707 OSTEOTECH, INC. GRAFTON PLUS DBM PASTE 11/30/2005
K080418 REGENERATION TECHNOLOGIES, INC. REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST 04/30/2008


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