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Osteotech Inc

FDA Regulatory Profile

Summary

Total Recalls
12
510(k) Clearances
24
Inspections
11
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0093-2013Class IIOptimum Expanse R Grafton is a human bone allograft product containing demineralized human bone tApril 20, 2012
Z-0088-2013Class IIGrafton DBM Matrix PLF Multiple Sizes Grafton is a human bone allograft product containing deminApril 20, 2012
Z-0091-2013Class IIGrafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product coApril 20, 2012
Z-0085-2013Class IIGrafton DBM Flex Multiple Sizes Grafton is a human bone allograft product containing demineralizApril 20, 2012
Z-0086-2013Class IIGrafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft product containing demineralApril 20, 2012
Z-0094-2013Class IIOptimum Expanse S Multiple sizes Grafton is a human bone allograft product containing demineraliApril 20, 2012
Z-0084-2013Class IIGrafton DBM Gel Multiple Sizes Grafton is a human bone allograft product containing demineralizeApril 20, 2012
Z-0083-2013Class IIGrafton DBM Putty Multiple Sizes Grafton is a human bone allograft product containing demineraliApril 20, 2012
Z-0092-2013Class IIGrafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product coApril 20, 2012
Z-0087-2013Class IIGrafton DBM Crunch Multiple Sizes Grafton is a human bone allograft product containing demineralApril 20, 2012
Z-0090-2013Class IIGrafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a human bone allograft product conApril 20, 2012
Z-0089-2013Class IIGrafton DBM Matrix Strips Multiple Sizes Grafton is a human bone allograft product containing deApril 20, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K082615GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVOctober 16, 2008
K081227PLEXUR MJuly 22, 2008
K080511PLEXUR-PApril 21, 2008
K073405PLEXUR MMarch 3, 2008
K061982PLEXUR PFebruary 7, 2007
K051188GRAFTON DBMJanuary 3, 2006
K051781GRAFTCAGE TLXDecember 16, 2005
K051195GRAFTON DBMDecember 16, 2005
K043209VIAGRAF DBM PASTEDecember 5, 2005
K053080GRAFTCAGE ACXDecember 1, 2005
K042707GRAFTON PLUS DBM PASTENovember 30, 2005
K043048GRAFTON PLUS DBM PASTENovember 23, 2005
K012254VBROctober 16, 2001
K003155VERTEBRAL BODY REPLACEMENTJanuary 4, 2001
K003384VERSALINK TITANIUM ROD-TO-ROD COUPLERSNovember 24, 2000
K992885VERSALOK LOW BACK FIXATION SYSTEMNovember 19, 1999
K991586SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)July 23, 1999
K973868SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)January 8, 1998
K971289SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)June 18, 1997
K955173SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)February 9, 1996