FDA 510(k) Applications Submitted by LAURA N KASPEROWICZ
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K130196 |
01/28/2013 |
SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR |
ARTHROCARE CORP. |
| K111044 |
04/15/2011 |
SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE |
ARTHROCARE CORPORATION |
| K111399 |
05/19/2011 |
SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75 |
ARTHROCARE CORP. |
| K151660 |
06/19/2015 |
MultiFIX S Knotless Fixation System |
ArthroCare Corporation |
| K081893 |
07/03/2008 |
OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500 |
ARTHROCARE CORP. |
| K151897 |
07/10/2015 |
MultiFIX« P Knotless Fixation Device |
ArthroCare Corporation |
| K172165 |
07/18/2017 |
Q-Fix Suture Anchor |
ArthroCare Corporation |
| K062244 |
08/03/2006 |
OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR |
ARTHROCARE CORP. |
| K163142 |
11/09/2016 |
SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader |
ArthroCare Corporation |
| K153313 |
11/17/2015 |
SpeedLock Knotless Fixation System |
ARTHROCARE CORPORATION |
| K153669 |
12/21/2015 |
MultiFIX S Ultra Knotless Fixation System |
ArthoCare Corporation |
| K070227 |
01/24/2007 |
OPUS MAGNUM PI KNOTLESS FIXATION DEVICE |
ARTHROCARE CORP. |
| K090380 |
02/17/2009 |
MAGNUM M FIXATION DEVICE |
ARTHROCARE CORP. |
| K100457 |
02/17/2010 |
OPUS SPEEDSCREW SYSTEM |
ARTHROCARE CORP. |
| K090615 |
03/09/2009 |
OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE |
ARTHROCARE CORP. |
| K070671 |
03/12/2007 |
OPUS SMARTSTITCH SUTURE DEVICE |
ARTHROCARE CORP. |
| K061349 |
05/15/2006 |
OPUS LABRALOCK P KNOTLESS FIXATION DEVICE |
ARTHROCARE CORP. |
| K071374 |
05/16/2007 |
OPUS TWINLOCK KNOTLESS FIXATION DEVICE |
ARTHROCARE CORP. |
| K091503 |
05/21/2009 |
MAGNUM MP FIXATION DEVICE |
ARTHROCARE CORP. |
| K101437 |
05/24/2010 |
SPEEDFIX SUTURE SYSTEM |
ARTHROCARE CORP. |
| K101448 |
05/24/2010 |
OPUS SPEEDSCREW SYSTEM |
ARTHROCARE CORP. |
| K081497 |
05/29/2008 |
OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503) |
ARTHROCARE CORP. |
| K041440 |
06/01/2004 |
OPUS MAGNUM ANCHOR WITH INSERTER |
OPUS MEDICAL, INC. |
| K042031 |
07/28/2004 |
OPUS SPEEDSTITCH SUTURE DEVICE |
OPUS MEDICAL, INC. |
| K042584 |
09/22/2004 |
OPUS MINIMAGNUM ANCHOR WITH INSERTER |
OPUS MEDICAL, INC. |
| K033317 |
10/15/2003 |
SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070 |
OPUS MEDICAL, INC. |
| K042914 |
10/21/2004 |
OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE |
OPUS MEDICAL, INC. |
| K083240 |
11/03/2008 |
OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES |
ARTHROCARE CORP. |
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