FDA 510(k) Applications Submitted by BLACKSTONE MEDICAL, INC.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K020600 |
02/22/2002 |
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) |
BLACKSTONE MEDICAL, INC. |
K020620 |
02/25/2002 |
BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) |
BLACKSTONE MEDICAL, INC. |
K020674 |
03/01/2002 |
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW |
BLACKSTONE MEDICAL, INC. |
K012184 |
07/12/2001 |
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM |
BLACKSTONE MEDICAL, INC. |
K022399 |
07/23/2002 |
BLACKSTONE SPINAL FIXATION SYSTEM SPACER |
BLACKSTONE MEDICAL, INC. |
K022605 |
08/06/2002 |
BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER |
BLACKSTONE MEDICAL, INC. |
K022965 |
09/06/2002 |
BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE |
BLACKSTONE MEDICAL, INC. |
K013558 |
10/25/2001 |
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW |
BLACKSTONE MEDICAL, INC. |
K013885 |
11/23/2001 |
BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS |
BLACKSTONE MEDICAL, INC. |
K003735 |
12/04/2000 |
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR |
BLACKSTONE MEDICAL, INC. |
K994217 |
12/15/1999 |
BLACKSTONE SPINAL FIXATION SYSTEM |
BLACKSTONE MEDICAL, INC. |
K100614 |
03/04/2010 |
HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES |
BLACKSTONE MEDICAL, INC. |
K040034 |
01/08/2004 |
BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER |
BLACKSTONE MEDICAL, INC. |
K030241 |
01/23/2003 |
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM |
BLACKSTONE MEDICAL, INC. |
K042100 |
08/04/2004 |
BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR |
BLACKSTONE MEDICAL, INC. |
K043338 |
12/03/2004 |
BLAKSTONE LAMINOPLASTY FIXATION SYSTEM |
BLACKSTONE MEDICAL, INC. |
K030197 |
01/21/2003 |
BLACKSTONE POSTERIOR CERVICAL SYSTEM |
BLACKSTONE MEDICAL, INC. |
K030581 |
02/24/2003 |
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) |
BLACKSTONE MEDICAL, INC. |
K030595 |
02/25/2003 |
BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM |
BLACKSTONE MEDICAL, INC. |
K030744 |
03/10/2003 |
BLACKSTONE SURGICAL TITANIUM MESH |
BLACKSTONE MEDICAL, INC. |
K030862 |
03/18/2003 |
BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR |
BLACKSTONE MEDICAL, INC. |
K050892 |
04/08/2005 |
HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM |
BLACKSTONE MEDICAL, INC. |
K051246 |
05/16/2005 |
CONSTRUX MINI PEEK VBR SYSTEM |
BLACKSTONE MEDICAL, INC. |
K041939 |
07/19/2004 |
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS |
BLACKSTONE MEDICAL, INC. |
K032700 |
09/02/2003 |
BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS |
BLACKSTONE MEDICAL, INC. |
K042514 |
09/16/2004 |
MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM |
BLACKSTONE MEDICAL, INC. |
K023498 |
10/18/2002 |
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM |
BLACKSTONE MEDICAL, INC. |
K033702 |
11/25/2003 |
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM |
BLACKSTONE MEDICAL, INC. |
K033980 |
12/23/2003 |
BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION) |
BLACKSTONE MEDICAL, INC. |
K043548 |
12/23/2004 |
BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM |
BLACKSTONE MEDICAL, INC. |
K972768 |
07/24/1997 |
BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM |
BLACKSTONE MEDICAL, INC. |
K061229 |
05/02/2006 |
UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM |
BLACKSTONE MEDICAL, INC. |
K974885 |
12/30/1997 |
BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM |
BLACKSTONE MEDICAL, INC. |
K093926 |
12/22/2009 |
FIREBIRD SPINAL FIXATION SYSTEM |
BLACKSTONE MEDICAL, INC. |
K080394 |
02/13/2008 |
BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM |
BLACKSTONE MEDICAL, INC. |
K080407 |
02/14/2008 |
BLACKSTONE SFS PARALLEL ROD CONNECTORS |
BLACKSTONE MEDICAL, INC. |
K081177 |
04/25/2008 |
BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM |
BLACKSTONE MEDICAL, INC. |
K081684 |
06/17/2008 |
BLACKSTONE PEDICLE SCREW SYSTEM |
BLACKSTONE MEDICAL, INC. |
K081849 |
06/30/2008 |
BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE |
BLACKSTONE MEDICAL, INC. |
K082235 |
08/07/2008 |
BLACKSTONE PILLAR XL PEEK SPACERS |
BLACKSTONE MEDICAL, INC. |
K092624 |
08/26/2009 |
FIREBIRD SPINAL FIXATION SYSTEM |
BLACKSTONE MEDICAL, INC. |
K082797 |
09/23/2008 |
BLACKSTONE PEDICLE SCREW SYSTEM |
BLACKSTONE MEDICAL, INC. |
K073420 |
12/05/2007 |
BLACKSTONE ASCENT MULTIAXIAL SCREWS |
BLACKSTONE MEDICAL, INC. |
K073654 |
12/26/2007 |
BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR |
BLACKSTONE MEDICAL, INC. |
K060350 |
02/10/2006 |
CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM |
BLACKSTONE MEDICAL, INC. |
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