FDA 510(k) Applications Submitted by NATALIE S HECK
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K040627 |
03/09/2004 |
DEPUY ASR MODULAR ACETABULAR CUP SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
| K071117 |
04/20/2007 |
MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS |
DEPUY ORTHOPAEDICS, INC. |
| K032659 |
08/28/2003 |
DEPUY ASR RESURFACING FEMORAL HEADS |
DEPUY ORTHOPAEDICS, INC. |
| K052472 |
09/08/2005 |
DEPUY GLOBAL SHOULDER CROSSLINK GLENOID |
DEPUY ORTHOPAEDICS, INC. |
| K033273 |
10/10/2003 |
DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS |
DEPUY ORTHOPAEDICS, INC. |
| K043058 |
11/05/2004 |
PINNACLE CONSTRAINED ACETABULAR LINERS |
DEPUY, INC. |
| K060696 |
03/16/2006 |
ACCLAIM TOTAL ELBOW SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
| K060864 |
03/30/2006 |
MULTIDIRECTIONAL THREADED PEG |
HAND INNOVATIONS, LLC. |
| K060874 |
03/30/2006 |
DEPUY GLOBAL AP SHOULDER SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
| K071135 |
04/23/2007 |
DEPUY CI HIP INSTRUMENTATION |
DEPUY ORTHOPAEDICS, INC. |
| K061144 |
04/25/2006 |
DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT |
DEPUY ORTHOPAEDICS, INC. |
| K071379 |
05/17/2007 |
DELTA XTEND REVERSE SHOULDER MODULAR STEM |
DEPUY ORTHOPAEDICS, INC. |
| K061748 |
06/21/2006 |
FRAGMENT PLATE SYSTEM |
HAND INNOVATIONS, LLC. |
| K062250 |
08/02/2006 |
DELTA XTEND REVERSE SHOULDER SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
| K053002 |
10/26/2005 |
DEPUY CMW 1 GENTAMICIN BONE CEMENT |
DEPUY ORTHOPAEDICS, INC. |
| K053003 |
10/26/2005 |
DEPUY CMW 1, 2 AND 3 BONE CEMENTS |
DEPUY ORTHOPAEDICS, INC. |
| K053445 |
12/12/2005 |
SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT |
DEPUY ORTHOPAEDICS, INC. |
| K053569 |
12/22/2005 |
AGILITY LP TOTAL ANKLE PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
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