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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