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 |
|
|