FDA 510(k) Applications Submitted by MARCIA J ARENTZ
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K100597 |
03/02/2010 |
HARMONIC FOCUS SHEARS |
ETHICON ENDO-SURGERY, LLC |
| K011047 |
04/06/2001 |
GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT |
DEPUY ORTHOPAEDICS, INC. |
| K000207 |
01/24/2000 |
POROCOAT PRODIGY HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
| K000575 |
02/22/2000 |
GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD |
DEPUY ORTHOPAEDICS, INC. |
| K960793 |
02/27/1996 |
SYNERMED ENZYMATIC CO2 REAGENT KIT |
SYNERMED, INC. |
| K010780 |
03/15/2001 |
TROCHANTERIC NAIL |
DEPUY ORTHOPAEDICS, INC. |
| K011099 |
04/11/2001 |
GLOBAL FX POROUS-COATED HUMERAL STEM |
DEPUY ORTHOPAEDICS, INC. |
| K001277 |
04/21/2000 |
TRIFLANGE ACETABULAR CUP SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
| K971491 |
04/24/1997 |
SYNERMED IR 200 CHEMISTRY ANALYZER |
SYNERMED, INC. |
| K011489 |
05/15/2001 |
SUMMIT DUOFIX HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
| K001738 |
06/07/2000 |
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT |
DEPUY ORTHOPAEDICS, INC. |
| K001778 |
06/13/2000 |
POROCOAT PRODIGY HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
| K962479 |
06/26/1996 |
SYNERMED ISE REAGENTS |
SYNERMED, INC. |
| K001991 |
06/29/2000 |
TITAN POROCOAT HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
| K972716 |
07/21/1997 |
SYNERMED TOTAL BILIRUBIN REAGENT KIT |
SYNERMED, INC. |
| K012364 |
07/26/2001 |
AML HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
| K973109 |
08/19/1997 |
SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT |
SYNERMED, INC. |
| K983304 |
09/21/1998 |
SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT |
SYNERMED INTL., INC. |
| K963939 |
10/01/1996 |
SYNERMED DIRECT BILIRUBIN REAGENT KIT |
SYNERMED, INC. |
| K013350 |
10/09/2001 |
MODIFICATION TO DEPUY C-STEM SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
| K013352 |
10/09/2001 |
SUMMIT CEMENTED HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
| K013430 |
10/16/2001 |
ACE BIO WIN TIBIAL NAILING SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
| K003235 |
10/17/2000 |
PE.R.I. II KNEE FRACTURE SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
| K013503 |
10/22/2001 |
MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR |
DEPUY ORTHOPAEDICS, INC. |
| K013563 |
10/26/2001 |
LONG TROCHANTERIC NAIL SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
| K003397 |
11/01/2000 |
COLLES C SERIES FRAME STERILE PACK |
DEPUY ORTHOPAEDICS, INC. |
| K003421 |
11/03/2000 |
DEPUY C-STEM SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
| K003797 |
12/08/2000 |
ACE AIM TTC FUSION NAIL |
DEPUY ORTHOPAEDICS, INC. |
| K003800 |
12/08/2000 |
AML HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
| K974909 |
12/31/1997 |
SYNERMED CREATININE REAGENT KIT |
SYNERMED INTL., INC. |
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