Bone Grafting Material, Human Source
Regulation 872.3930
0510(k)s in 12 months (15 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NUN
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 3 | 0 |
| Isotis NV | 2 | 0 |
| Musculoskeletal Transplant Foundation | 2 | 0 |
| Osteotech, Inc. | 2 | 0 |
| Biomet 3i | 1 | 0 |
| Biomet Interpore Cross | 1 | 0 |
| Exactech, Inc. | 1 | 0 |
| Hans Biomed Corp. | 1 | 0 |
| Isotis Orthobiologics, Inc. | 1 | 0 |
| Regeneration Technologies, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 10, 2014 | K130235 | SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY Hans Biomed Corp. | NUN |
| Jan 20, 2012 | K113645 | REGENEROSS ALLOGRAFT PLUS MINERLIZED Biomet Interpore Cross | NUN |
| Aug 12, 2011 | K103699 | EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC Exactech, Inc. | NUN |
| Oct 2, 2009 | K091217 | DBX DEMINERALIZED BONE MATRIX PUTTY Musculoskeletal Transplant Foundation | NUN |
| Nov 10, 2008 | K082463 | PROGENIX Medtronic Sofamor Danek | NUN |
| Jul 18, 2008 | K081950 | PROGENIX PLUS Medtronic Sofamor Danek, Inc. | NUN |
| May 13, 2008 | K080462 | PROGENIX DBM PUTTY Medtronic Sofamor Danek | NUN |
| Apr 30, 2008 | K080418 | REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST Regeneration Technologies, Inc. | NUN |
| May 14, 2007 | K070147 | INTERGRO ORAL Biomet 3i | NUN |
| Mar 29, 2006 | K060332 | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY Isotis NV, NL | NUN |
| Mar 27, 2006 | K060306 | ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY Isotis NV | NUN |
| Jan 3, 2006 | K051188 | GRAFTON DBM Osteotech, Inc. | NUN |
| Nov 30, 2005 | K042707 | GRAFTON PLUS DBM PASTE Osteotech, Inc. | NUN |
| Jul 29, 2005 | K043573 | DYNAGRAFT II DENTAL Isotis Orthobiologics, Inc. | NUN |
| Apr 29, 2005 | K040501 | DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX Musculoskeletal Transplant Foundation | NUN |
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