FDA 510(k) Applications Submitted by Denise Duchene
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K960250 |
01/16/1996 |
VACUTAINER BRAND PLUS SERUM & SST TUBES |
BECTON DICKINSON VACUTAINER SYSTEMS |
| K100605 |
03/03/2010 |
MIS SYSTEM |
SPINE WAVE, INC. |
| K250877 |
03/24/2025 |
TMINI Miniature Robotic System |
THINK Surgical, Inc. |
| K030978 |
03/28/2003 |
SCORPIO NRG KNEE SYSTEM |
HOWMEDICA OSTEONICS CORP. |
| K090899 |
04/01/2009 |
DEPUY SPINE LATERAL SYSTEM |
DEPUY SPINE, INC. |
| K091396 |
05/10/2009 |
CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM |
CARDO MEDICAL CORP. |
| K111469 |
05/27/2011 |
STAXXSD SYSTEM |
SPINE WAVE, INC. |
| K032163 |
07/15/2003 |
DURACON TOTAL KNEE SYSTEM |
HOWMEDICA OSTEONICS CORP. |
| K082128 |
07/29/2008 |
DEPUY SPINE LATERAL CAGE SYSTEM |
DEPUY SPINE |
| K032418 |
08/05/2003 |
DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING |
HOWMEDICA OSTEONICS CORP. |
| K102315 |
08/16/2010 |
STAXX XDL SYSTEM |
SPINE WAVE, INC. |
| K042343 |
08/30/2004 |
SCORPIO NRG KNEE SYSTEM |
HOWMEDICA OSTEONICS CORP |
| K002711 |
08/31/2000 |
HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER |
HOLOGIC, INC. |
| K092803 |
09/11/2009 |
CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT |
CARDO MEDICAL CORP. |
| K033342 |
10/17/2003 |
SCORPIO KNEE SYSTEM - TIBIAL INSERTS |
HOWMEDICA OSTEONICS CORP. |
| K042883 |
10/19/2004 |
SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT |
HOWMEDICA OSTEONICS CORP |
| K042993 |
11/01/2004 |
TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT |
HOWMEDICA OSTEONICS CORP |
| K243481 |
11/08/2024 |
TMINI Miniature Robotic System |
THINK Surgical, Inc. |
| K033716 |
11/26/2003 |
TRIDENT ACETABULAR SYSTEM |
HOWMEDICA OSTEONICS CORP |
| K033769 |
12/03/2003 |
EIUS UNICOMPARTMENTAL KNEE SYSTEM |
HOWMEDICA OSTEONICS CORP |
| K043374 |
12/08/2004 |
DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING |
HOWMEDICA OSTEONICS CORP |
| K033971 |
12/22/2003 |
SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING |
HOWMEDICA OSTEONICS CORP |
| K033972 |
12/22/2003 |
SCORPIO TOTAL KNEE SYSTEM |
HOWMEDICA OSTEONICS CORP |
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