FDA 510(k) Applications Submitted by HOWARD L SCHRAYER

FDA 510(k) Number Submission Date Device Name Applicant
K060165 01/23/2006 AXYAFLEX POLYESTER SUTURE AXYA MEDICAL, INC.
K070253 01/26/2007 AXYA SUTURE WELDING SYSTEM AND KIT AXYA MEDICAL, INC.
K080335 02/07/2008 TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM TORNIER, INC.
K050524 03/02/2005 EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 MARDA MEDICAL, INC.
K921287 03/17/1992 SURGICAL RETRACTOR ADVANCED SURGICAL, INC.
K060970 04/07/2006 AXYALOOP NONABSORBABLE BONE ANCHOR AXYA MEDICAL, INC.
K061131 04/24/2006 DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY ORTHOCON, INC.
K141502 06/06/2014 HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY ORTHOCON, INC.
K041698 06/22/2004 AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR AXYA MEDICAL, INC.
K152005 07/20/2015 MONTAGE Settable, Resorbable Hemostatic Bone Putty ORTHOCON, INC.
K051983 07/22/2005 MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR AXYA MEDICAL, INC.
K033053 09/29/2003 ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM ALVEOLUS, INC.
K123243 10/17/2012 HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY ORTHOCON, INC.
K043260 11/24/2004 ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY ORTHOCON, LLC
K091321 05/05/2009 OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY BACTERIN INTERNATIONAL INC.
K140117 01/16/2014 AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY ORTHOCON, INC.
K110143 01/18/2011 HET BIPOLAR ELECTROCAUTERY FORCEPS HET SYSTEMS, LLC
K990193 01/21/1999 IODINE BRACHYTHERAPY SEEDS, MODEL 3000 IMPLANT SCIENCES CORP.
K140422 02/18/2014 HET SYSTEMS, LLC, HET BIPOLAR LIGATOR SYSTEM HET SYSTEMS, LLC
K130498 02/26/2013 OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY BACTERIN INTERNATIONAL INC.
K150621 03/11/2015 OsteoSelect PLUS Demineralized Bone Matrix Putty BACTERIN INTERNATIONAL INC.
K980988 03/17/1998 AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) AXYA MEDICAL, INC.
K070773 03/21/2007 AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR AXYA MEDICAL, INC.
K030947 03/26/2003 ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM ALVEOLUS, INC.
K111337 05/12/2011 TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD TORNIER, INC.
K051250 05/16/2005 AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR AXYA MEDICAL, INC.
K021929 06/12/2002 AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM AXYA MEDICAL, INC.
K011912 06/19/2001 MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000 AXYA MEDICAL, INC.
K091870 06/23/2009 TORNIER, PITON FIXATION IMPLANT SYSTEM TORNIER
K022207 07/08/2002 AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM AXYA MEDICAL, INC.
K992405 07/20/1999 AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK) AXYA MEDICAL, INC.
K132461 08/07/2013 A.I.M. SUTURE ANCHOR ANCHOR INNOVATION MEDICAL, INC.
K002435 08/09/2000 MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK) AXYA MEDICAL, INC.
K002557 08/17/2000 SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN) AXYA MEDICAL, INC.
K142339 08/21/2014 HEMASORB Resorbable Hemostatic Bone Putty ORTHOCON, LLC
K945369 08/25/1994 LAPAROSCOPIC SURGICAL INSTRUMENTS FOR GENERAL USE ADVANCED SURGICAL, INC.
K983108 09/04/1998 SUTURE WELDING SYSTEM AND KIT (SWK) AXYA MEDICAL, INC.
K032744 09/04/2003 ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM ALVEOLUS, INC.
K052491 09/12/2005 AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR AXYA MEDICAL, INC.
K063194 10/20/2006 TUFFLEX POLYESTER SUTURE AXYA MEDICAL, INC.
K143069 10/27/2014 HEMASORBPLUS press Resorable Hemostatic Bone Putty ORTHOCON, INC.
K063330 11/03/2006 ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY ORTHOCON, INC.
K103262 11/04/2010 QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM TORNIER, INC.
K083268 11/05/2008 TORNIER, INC., INSITE SUTURE ANCHORS TORNIER, INC.
K093799 12/10/2009 TORNIER SURGICAL MESH TORNIER, INC.
K994313 12/22/1999 MODIFICATION TO BONE ANCHOR AND KIT (BAK) AXYA MEDICAL, INC.
K994317 12/22/1999 I-PLANT, MODEL 3500 IMPLANT SCIENCES CORP.
K003971 12/22/2000 AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR AXYA MEDICAL, INC.
K033990 12/23/2003 ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM ALVEOLUS, INC.
K170326 02/02/2017 dynaMX Intramedullary Implant Arthrex, Inc.
K160427 02/16/2016 dynaMX(TM) Nitinol Compression Screw MX ORTHOPEDICS CORP.
K180701 03/16/2018 SafePath Suturing System SafePath Medical, Inc.
K191140 04/30/2019 MONTAGE-QS Settable, Resorbable Hemostatic Bone Orthocon, Inc.
K161303 05/10/2016 dynaMXÖ Compression Plate MX ORTHOPEDICS, CORP.
K153129 10/30/2015 dynaMX Tabbed Staple MX Orthopedics, Corp.
K153317 11/18/2015 HEMASORBPLUS Resorbable Hemostatic Bone Putty ORTHOCON, INC.
K143622 12/22/2014 dynaMX Compression Staple MX Orthopedics, Corp.


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