FDA 510(k) Applications Submitted by ARLENE SAULL
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K963393 |
08/28/1996 |
MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT |
DEPUY, INC. |
| K963973 |
10/03/1996 |
DEPUY CANNULATED CROSS PIN SCREW SYSTEM |
DEPUY, INC. |
| K010171 |
01/18/2001 |
DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER |
DEPUY ORTHOPAEDICS, INC. |
| K000392 |
02/07/2000 |
RESPONSE 2000 HIP STEM |
DEPUY ORTHOPAEDICS, INC. |
| K010367 |
02/07/2001 |
MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM |
DEPUY ORTHOPAEDICS, INC. |
| K000432 |
02/09/2000 |
RESPONSE 2000 CEMENTED HIP STEM |
DEPUY ORTHOPAEDICS, INC. |
| K971730 |
05/09/1997 |
DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY, INC. |
| K971742 |
05/12/1997 |
DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT |
DEPUY, INC. |
| K001982 |
06/29/2000 |
TRI-LOCK HIP STEM |
DEPUY ORTHOPAEDICS, INC. |
| K982483 |
07/17/1998 |
DEPUY MOTECH PEAK FIXATION SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
| K002441 |
08/09/2000 |
FENNING HIP STEM |
DEPUY ORTHOPAEDICS, INC. |
| K993465 |
10/13/1999 |
DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE |
DEPUY, INC. |
| K974044 |
10/24/1997 |
GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD |
DEPUY ORTHOPAEDICS, INC. |
| K984158 |
11/19/1998 |
P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY |
DEPUY, INC. |
| K003875 |
12/15/2000 |
TI-REPLICA HIP STEM |
DEPUY ORTHOPAEDICS, INC. |
| K974740 |
12/19/1997 |
DEPUY TRI-LOCK HIP STEM |
DEPUY, INC. |
| K984541 |
12/21/1998 |
GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD |
DEPUY ORTHOPAEDICS, INC. |
| K980794 |
03/02/1998 |
DUAL LOCK HIP STEM |
DEPUY, INC. |
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