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Orthovita, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
26
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K163621Vitoss Bioactive (BA) InjectableMay 2, 2017
K161447HydroSet XTOctober 6, 2016
K153608Vitoss BiModal Bone Graft Substitute Foam StripFebruary 12, 2016
K153306Imbibe NeedleDecember 18, 2015
K140868STRYKER KWIC NEEDLEJune 5, 2014
K140414IMBIBE NEEDLEApril 1, 2014
K103173VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTEFebruary 7, 2011
K101171ORTHOVITA PEEK SPACERJanuary 25, 2011
K102545FM-02 BONE GRAFT SUBSTITUTEOctober 27, 2010
K091618VITOMATRIXSeptember 27, 2010
K080108CORTOSS BONE AUGMENTATION MATERIALJune 5, 2009
K083033VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFNovember 6, 2008
K081439VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTEJune 17, 2008
K072184VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTESeptember 18, 2007
K052173VITAGEL SURGICAL HEMOSTAT SPRAY SETOctober 19, 2005
K050795IMBIBE BONE MARROW ASPIRATION NEEDLEJune 3, 2005
K032288VITOSS SCAFFOLD FOAM BONE GRAFT MATERIALDecember 19, 2003
K032812ENDOSKELETON TA VERTEBRAL BODY REPLACEMENTDecember 8, 2003
K032130VITOSS-FILLED CARTRIDGENovember 5, 2003
K032409VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLERAugust 29, 2003