FDA 510(k) Applications Submitted by DEBBIE DE LOS SANTOS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K000020 |
01/04/2000 |
MODIFICATION TO ISOBAR SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
| K990118 |
01/13/1999 |
ISOBAR SPINAL SYSTEM |
SCIEN'TX USA INC. |
| K980473 |
02/06/1998 |
PRESS-FIT STEM |
ENCORE ORTHOPEDICS, INC. |
| K000425 |
02/09/2000 |
ISOBAR SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
| K040354 |
02/12/2004 |
METAL/METAL HIP SYSTEM |
ENCORE MEDICAL, L.P. |
| K000521 |
02/16/2000 |
KEYSTONE HIP |
ENCORE ORTHOPEDICS, INC. |
| K040397 |
02/17/2004 |
MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM |
ENCORE MEDICAL, L.P. |
| K000590 |
02/21/2000 |
LATERAL PIVOT INSERT |
ENCORE ORTHOPEDICS, INC. |
| K030667 |
03/03/2003 |
ENCORE ANTERIOR SPINAL STAPLE SYSTEM |
ENCORE MEDICAL, L.P. |
| K980854 |
03/05/1998 |
RETROGRADE PEDIATRIC NAIL |
ENCORE ORTHOPEDICS, INC. |
| K990721 |
03/05/1999 |
ISOLOCK SPINAL SYSTEM |
SCIEN'TX USA INC. |
| K991226 |
04/12/1999 |
FOUNDATION POROUS HIP STEM |
ENCORE ORTHOPEDICS, INC. |
| K991227 |
04/12/1999 |
8MM FORGED CEMENTED STEM |
ENCORE ORTHOPEDICS, INC. |
| K031214 |
04/17/2003 |
CYCLONE ANTERIOR CERVICAL PLATE SYSTEM |
ENCORE MEDICAL, L.P. |
| K991325 |
04/19/1999 |
MODIFICATION OF ENCORE LINEAR POROUS COATED HIP |
ENCORE ORTHOPEDICS, INC. |
| K991326 |
04/19/1999 |
ISOBAR SEMI-RIGID SPINAL SYSTEM |
SCIEN'TX USA INC. |
| K041066 |
04/23/2004 |
ENCORE REVERSE SHOULDER PROSTHESIS |
ENCORE MEDICAL, L.P. |
| 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. |
| K974093 |
10/30/1997 |
FOUNDATION POROUS COATED HEMISPHERICAL SHELL |
ENCORE ORTHOPEDICS, INC. |
| K974095 |
10/30/1997 |
FOUNDATION POROUS COATED FLARED RIM SHELL |
ENCORE ORTHOPEDICS, INC. |
| K993841 |
11/12/1999 |
CEMSTOP CEMENT RESTRICTOR |
ENCORE ORTHOPEDICS, INC. |
| K023794 |
11/13/2002 |
CONSTRAINED LINER |
ENCORE MEDICAL, L.P. |
| 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. |
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