Etex Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K100883CARRIGENDecember 21, 2010
K101557GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGENJuly 1, 2010
K093447CARRIGENFebruary 18, 2010
K091729ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONEDecember 23, 2009
K091607ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONENovember 2, 2009
K090855EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTESeptember 18, 2009
K090310EQUIVABONEMarch 24, 2009
K090242GAMMA-BSM, BETA-BSMFebruary 20, 2009
K080329CAP PLUS, EQUIVABONE, CAP/DBMApril 28, 2008
K063050CAP PLUSNovember 19, 2007
K072636A-BSM BONE SUBSTITUTE MATERIALOctober 23, 2007
K072355OSSIFUSE BONE SUBSTITUTE MATERIALSeptember 26, 2007
K062630OSSIPRO BONE SUBSTITUTE MATERIALJune 28, 2007
K033138CAP3 BONE SUBSTITUTE MATERIALDecember 2, 2003
K032307CAP BONE SUBSTITUTE MATERIALOctober 24, 2003
K983009BSM- BONE SUBSTITUTE MATERIALNovember 25, 1998
K962548BSM BONE SUBSTITUTE MATERIAL KITAugust 5, 1997
K935696ETEX HA HIP REPLACEMENT SYSTEMJuly 22, 1994
K925895ETEX HIP REPLACEMENT SYSTEMFebruary 9, 1993
K913417ETEX DENTAL IMPLANT SYSTEMFebruary 19, 1992