FDA 510(k) Applications Submitted by ORTHOVITA, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K030208 |
01/21/2003 |
IMBIBE II SYRINGE |
ORTHOVITA, INC. |
| K032409 |
08/04/2003 |
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER |
ORTHOVITA, INC. |
| K023074 |
09/16/2002 |
IMBIBE BONE MARROW ASPIRATION SYRINGE |
ORTHOVITA, INC. |
| K032130 |
07/11/2003 |
VITOSS-FILLED CARTRIDGE |
ORTHOVITA, INC. |
| K011087 |
04/10/2001 |
ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE |
ORTHOVITA, INC. |
| K101171 |
04/26/2010 |
ORTHOVITA PEEK SPACER |
ORTHOVITA, INC. |
| K081439 |
05/22/2008 |
VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE |
ORTHOVITA, INC. |
| K032812 |
09/09/2003 |
ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT |
ORTHOVITA, INC. |
| K091618 |
06/03/2009 |
VITOMATRIX |
ORTHOVITA, INC. |
| K102545 |
09/03/2010 |
FM-02 BONE GRAFT SUBSTITUTE |
ORTHOVITA, INC. |
| K083033 |
10/10/2008 |
VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM & BIOACTIVE FOAM BONE GRAFT SUBSTITUTE |
ORTHOVITA, INC. |
| K103173 |
10/28/2010 |
VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE |
ORTHOVITA, INC. |
| K080108 |
01/15/2008 |
CORTOSS BONE AUGMENTATION MATERIAL |
ORTHOVITA, INC. |
| K032288 |
07/24/2003 |
VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL |
ORTHOVITA, INC. |
| K072184 |
08/06/2007 |
VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE |
ORTHOVITA, INC. |
| K052173 |
08/10/2005 |
VITAGEL SURGICAL HEMOSTAT SPRAY SET |
ORTHOVITA, INC. |
| K050795 |
03/29/2005 |
IMBIBE BONE MARROW ASPIRATION NEEDLE |
ORTHOVITA, INC. |
| K163621 |
12/22/2016 |
Vitoss Bioactive (BA) Injectable |
Orthovita, Inc. |
| K140414 |
02/18/2014 |
IMBIBE NEEDLE |
ORTHOVITA, INC. |
| K140868 |
04/03/2014 |
STRYKER KWIC NEEDLE |
ORTHOVITA, INC. |
| K153306 |
11/16/2015 |
Imbibe Needle |
ORTHOVITA, INC. |
| K153608 |
12/17/2015 |
Vitoss BiModal Bone Graft Substitute Foam Strip |
ORTHOVITA, INC. |
| K161447 |
05/25/2016 |
HydroSet XT |
ORTHOVITA, INC. |
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