FDA 510(k) Applications Submitted by ENCORE ORTHOPEDICS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K960906 |
03/05/1996 |
FOUNDATION GLENOID COMPONENT |
ENCORE ORTHOPEDICS, INC. |
| K963998 |
10/07/1996 |
METAL BACKED ACETABULAR COMPONENT |
ENCORE ORTHOPEDICS, INC. |
| K961360 |
04/09/1996 |
TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM |
ENCORE ORTHOPEDICS, INC. |
| K955563 |
12/06/1995 |
FOUNDATION FORGED, TEXTURED & POROUS STEMS W/BIOLOX CERAMIC HEADS |
ENCORE ORTHOPEDICS, INC. |
| K970031 |
01/03/1997 |
FOUNDATION KNEE SYSTEM TIBIAL COMPONENT |
ENCORE ORTHOPEDICS, INC. |
| K960107 |
01/11/1996 |
DDS SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
| K960633 |
02/14/1996 |
PRESS-FIT FLARED SHELL |
ENCORE ORTHOPEDICS, INC. |
| K961526 |
04/22/1996 |
PRESS-FIT POROUS SHELL |
ENCORE ORTHOPEDICS, INC. |
| K961890 |
05/15/1996 |
FOUNDATION 9MM FORGED CEMENTED STEM |
ENCORE ORTHOPEDICS, INC. |
| K962560 |
07/01/1996 |
VITALITY HIP STEM |
ENCORE ORTHOPEDICS, INC. |
| K972791 |
07/28/1997 |
ENCORE LINEAR HIP |
ENCORE ORTHOPEDICS, INC. |
| K963028 |
08/05/1996 |
TIBIAL INSERT |
ENCORE ORTHOPEDICS, INC. |
| K973119 |
08/20/1997 |
FOUNDATION POROUS ACETABULAR SYSTEM |
ENCORE ORTHOPEDICS, INC. |
| K964008 |
10/07/1996 |
FOUNDATION KNEE SYSTEM |
ENCORE ORTHOPEDICS, INC. |
| K964178 |
10/18/1996 |
PRESS-FIT HIP STEM |
ENCORE ORTHOPEDICS, INC. |
| K964227 |
10/23/1996 |
METAL ACETABULAR COMPONENT |
ENCORE ORTHOPEDICS, INC. |
| K965002 |
12/16/1996 |
ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND |
ENCORE ORTHOPEDICS, INC. |
| K001024 |
03/30/2000 |
PASS SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
| K000020 |
01/04/2000 |
MODIFICATION TO ISOBAR SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
| K980473 |
02/06/1998 |
PRESS-FIT STEM |
ENCORE ORTHOPEDICS, INC. |
| K000425 |
02/09/2000 |
ISOBAR SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
| K000521 |
02/16/2000 |
KEYSTONE HIP |
ENCORE ORTHOPEDICS, INC. |
| K000590 |
02/21/2000 |
LATERAL PIVOT INSERT |
ENCORE ORTHOPEDICS, INC. |
| K980854 |
03/05/1998 |
RETROGRADE PEDIATRIC NAIL |
ENCORE ORTHOPEDICS, INC. |
| K991226 |
04/12/1999 |
FOUNDATION POROUS HIP STEM |
ENCORE ORTHOPEDICS, INC. |
| K991227 |
04/12/1999 |
8MM FORGED CEMENTED STEM |
ENCORE ORTHOPEDICS, INC. |
| K991325 |
04/19/1999 |
MODIFICATION OF ENCORE LINEAR POROUS COATED HIP |
ENCORE ORTHOPEDICS, INC. |
| K991603 |
05/10/1999 |
GRIT BLASTED HUMERAL STEM |
ENCORE ORTHOPEDICS, INC. |
| K991889 |
06/03/1999 |
ULTIMAX HAIG II NAIL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
| K982160 |
06/19/1998 |
HINGED KNEE |
ENCORE ORTHOPEDICS, INC. |
| K982663 |
07/30/1998 |
STIMULAN- CALCIUM SULFATE BONE VOID FILLER |
ENCORE ORTHOPEDICS, INC. |
| K992738 |
08/13/1999 |
ISOBAR SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
| K973302 |
09/03/1997 |
FOUNDATION POROUS HIP STEM |
ENCORE ORTHOPEDICS, INC. |
| K973614 |
09/23/1997 |
FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES |
ENCORE ORTHOPEDICS, INC. |
| K973672 |
09/26/1997 |
FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA |
ENCORE ORTHOPEDICS, INC. |
| K973685 |
09/26/1997 |
REVELATION POROUS HIP STEM |
ENCORE ORTHOPEDICS, INC. |
| K973809 |
10/06/1997 |
FOUNDATION FRACTURE STEM |
ENCORE ORTHOPEDICS, INC. |
| K003250 |
10/17/2000 |
FMP METAL/METAL ACETABULAR INSERT |
ENCORE ORTHOPEDICS, INC. |
| K993630 |
10/27/1999 |
BIOLOK SCREW |
ENCORE ORTHOPEDICS, INC. |
| K974095 |
10/30/1997 |
FOUNDATION POROUS COATED FLARED RIM SHELL |
ENCORE ORTHOPEDICS, INC. |
| K974093 |
10/30/1997 |
FOUNDATION POROUS COATED HEMISPHERICAL SHELL |
ENCORE ORTHOPEDICS, INC. |
| K993841 |
11/12/1999 |
CEMSTOP CEMENT RESTRICTOR |
ENCORE ORTHOPEDICS, INC. |
| K974294 |
11/14/1997 |
ENCORE LINEAR POROUS COATED HIP |
ENCORE ORTHOPEDICS, INC. |
| K993943 |
11/19/1999 |
ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA |
ENCORE ORTHOPEDICS, INC. |
| K994070 |
12/02/1999 |
REVELATION POROUS HIP STEM |
ENCORE ORTHOPEDICS, INC. |
| K991790 |
05/26/1999 |
ULTIMAX ANKLE FUSION ROD SYSTEM |
ENCORE ORTHOPEDICS, INC. |
| K992109 |
06/22/1999 |
ENCORE FULLY COATED HIP |
ENCORE ORTHOPEDICS, INC. |
| K954053 |
08/29/1995 |
BERLIN EXTERNAL FIXATOR |
ENCORE ORTHOPEDICS, INC. |
| K002941 |
09/21/2000 |
ACETABULAR PLATES |
ENCORE ORTHOPEDICS, INC. |
| K020114 |
01/11/2002 |
3D KNEE |
ENCORE ORTHOPEDICS, INC. |
| K020170 |
01/17/2002 |
KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP |
ENCORE ORTHOPEDICS, INC. |
| K020236 |
01/23/2002 |
MODIFICATION TO PASS SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
| K020741 |
03/06/2002 |
UNICONDYLAR KNEE |
ENCORE ORTHOPEDICS, INC. |
| K011856 |
06/13/2001 |
RADIOGRAPHIC MARKERS |
ENCORE ORTHOPEDICS, INC. |
| K012175 |
07/12/2001 |
PASS SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
| K002959 |
09/22/2000 |
MODIFICATION TO ISOBAR SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
| K013191 |
09/24/2001 |
PASS SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
| K013431 |
10/16/2001 |
PASS SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
| K013442 |
10/17/2001 |
PASS SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
| K013490 |
10/22/2001 |
CEMENTED CALCAR HIP SYSTEM |
ENCORE ORTHOPEDICS, INC. |
| K003324 |
10/24/2000 |
PLASMA SPRAYED SHOULDER |
ENCORE ORTHOPEDICS, INC. |
| K001847 |
06/19/2000 |
ANTERIOR CERVICAL PLATE SYSTEM |
ENCORE ORTHOPEDICS, INC. |
| K032905 |
09/17/2003 |
3DKNEE POROUS COATED FEMORAL COMPONENT |
ENCORE ORTHOPEDICS, INC. |
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