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Synthes Spine

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
36
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K122211SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTSDecember 17, 2012
K120838SYNTHES MATRIX SYSTEMJuly 31, 2012
K111048SYNTHES SCOUT TACK FIXATIONJune 14, 2012
K120928SYNTHES MATRIX SYSTEMMay 18, 2012
K120571SYNTHES USS CONNECTORMay 14, 2012
K113149SYNTHES USS CONNECTORSFebruary 1, 2012
K113044SYNTHES MIRSDecember 21, 2011
K111358SYNTHES USSNovember 18, 2011
K103558SYNTHES SCOUT VESSEL GUARDFebruary 18, 2011
K103287SYNTHES 6.0 COCR AND CPT TI-3 RODSJanuary 5, 2011
K093762SYNTHES ZERO-PDecember 20, 2010
K100952MODIFICATION TO SYNTHES MATRIX SYSTEMAugust 5, 2010
K100089SYNTHES T-PAL SPACERMay 13, 2010
K091159SYNTHES ORACLE PLATEJuly 10, 2009
K090549SYNTHES SYNAPSE TRANSCONNECTORMay 21, 2009
K082914CLAMPFIXDecember 11, 2008
K082572USS ILIOSACRAL, USS POLYAXIALNovember 24, 2008
K072791ORACLE SPACER, OPAL SPACERDecember 26, 2007
K071667SYNTHES VECTRA-ONE SYSTEMNovember 30, 2007
K051665SYNTHES VECTRA-T SYSTEMSeptember 9, 2005