FDA 510(k) Applications Submitted by HOWARD J 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. |
K060970 |
04/07/2006 |
AXYALOOP NONABSORBABLE BONE ANCHOR |
AXYA MEDICAL, INC. |
K061131 |
04/24/2006 |
DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY |
ORTHOCON, INC. |
K211443 |
05/10/2021 |
AIBOLIT 3D+ |
AIbolit Technologies, LLC |
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. |
K202363 |
08/19/2020 |
HBP7 Settable Hemostatic Bone Putty |
Orthocon, 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. |
K213418 |
10/20/2021 |
MONTAGE Settable, Resorbable Hemostatic Bone Putty |
Orthocon, Inc. |
K193052 |
11/01/2019 |
HBP6 Settable, Resorbable Hemostatic Bone Paste |
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 |
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. |
K994317 |
12/22/1999 |
I-PLANT, MODEL 3500 |
IMPLANT SCIENCES CORP. |
K994313 |
12/22/1999 |
MODIFICATION TO BONE ANCHOR AND KIT (BAK) |
AXYA MEDICAL, INC. |
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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