Company ยท US
Encore Orthopedics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2004. Name variants (Inc, Corp, punctuation) are merged.
85510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 16 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 13 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 11 |
| MNI | Orthosis, Spinal Pedicle Fixation | 5 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 4 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 4 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 3 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 3 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 |
| HWC | Screw, Fixation, Bone | 2 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | 2 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 1 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 |
| HTY | Pin, Fixation, Smooth | 1 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 1 |
| JDQ | Cerclage, Fixation | 1 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 6, 2004 | K032905 | 3DKNEE POROUS COATED FEMORAL COMPONENT Encore Orthopedics, Inc. | MBH |
| Jul 12, 2002 | K020114 | 3D KNEE Encore Orthopedics, Inc. | JWH |
| Jun 4, 2002 | K020741 | UNICONDYLAR KNEE Encore Orthopedics, Inc. | HRY |
| Feb 14, 2002 | K020236 | MODIFICATION TO PASS SPINAL SYSTEM Encore Orthopedics, Inc. | KWP |
| Feb 11, 2002 | K020170 | KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP Encore Orthopedics, Inc. | LPH |
| Jan 17, 2002 | K013490 | CEMENTED CALCAR HIP SYSTEM Encore Orthopedics, Inc. | LPH |
| Jan 15, 2002 | K013442 | PASS SPINAL SYSTEM Encore Orthopedics, Inc. | KWP |
| Dec 6, 2001 | K003324 | PLASMA SPRAYED SHOULDER Encore Orthopedics, Inc. | KWS |
| Nov 15, 2001 | K013431 | PASS SPINAL SYSTEM Encore Orthopedics, Inc. | MNI |
| Oct 24, 2001 | K013191 | PASS SPINAL SYSTEM Encore Orthopedics, Inc. | MNI |
| Aug 22, 2001 | K011856 | RADIOGRAPHIC MARKERS Encore Orthopedics, Inc. | NEU |
| Jul 31, 2001 | K012175 | PASS SPINAL SYSTEM Encore Orthopedics, Inc. | MNI |
| Jan 25, 2001 | K003250 | FMP METAL/METAL ACETABULAR INSERT Encore Orthopedics, Inc. | KWA |
| Dec 4, 2000 | K002941 | ACETABULAR PLATES Encore Orthopedics, Inc. | LWJ |
| Oct 16, 2000 | K002959 | MODIFICATION TO ISOBAR SPINAL SYSTEM Encore Orthopedics, Inc. | KWP |
| Aug 24, 2000 | K001847 | ANTERIOR CERVICAL PLATE SYSTEM Encore Orthopedics, Inc. | KWQ |
| May 23, 2000 | K001024 | PASS SPINAL SYSTEM Encore Orthopedics, Inc. | MNH |
| May 11, 2000 | K000590 | LATERAL PIVOT INSERT Encore Orthopedics, Inc. | JWH |
| May 10, 2000 | K000521 | KEYSTONE HIP Encore Orthopedics, Inc. | LPH |
| May 4, 2000 | K993841 | CEMSTOP CEMENT RESTRICTOR Encore Orthopedics, Inc. | LZN |
| Apr 26, 2000 | K993630 | BIOLOK SCREW Encore Orthopedics, Inc. | HWC |
| Mar 7, 2000 | K000425 | ISOBAR SPINAL SYSTEM Encore Orthopedics, Inc. | MNI |
| Feb 4, 2000 | K993943 | ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA Encore Orthopedics, Inc. | MEH |
| Feb 3, 2000 | K000020 | MODIFICATION TO ISOBAR SPINAL SYSTEM Encore Orthopedics, Inc. | MNH |
| Jan 20, 2000 | K994070 | REVELATION POROUS HIP STEM Encore Orthopedics, Inc. | LPH |
| Nov 8, 1999 | K992738 | ISOBAR SPINAL SYSTEM Encore Orthopedics, Inc. | MNI |
| Aug 12, 1999 | K992109 | ENCORE FULLY COATED HIP Encore Orthopedics, Inc. | LPH |
| Aug 12, 1999 | K991889 | ULTIMAX HAIG II NAIL SYSTEM Encore Orthopedics, Inc. | LXT |
| Aug 6, 1999 | K991790 | ULTIMAX ANKLE FUSION ROD SYSTEM Encore Orthopedics, Inc. | HSB |
| Jun 29, 1999 | K991603 | GRIT BLASTED HUMERAL STEM Encore Orthopedics, Inc. | KWT |
| Jun 25, 1999 | K991325 | MODIFICATION OF ENCORE LINEAR POROUS COATED HIP Encore Orthopedics, Inc. | LPH |
| Jun 1, 1999 | K991227 | 8MM FORGED CEMENTED STEM Encore Orthopedics, Inc. | JDI |
| Jun 1, 1999 | K991226 | FOUNDATION POROUS HIP STEM Encore Orthopedics, Inc. | LZO |
| Mar 17, 1999 | K982160 | HINGED KNEE Encore Orthopedics, Inc. | KRO |
| Feb 26, 1999 | K982663 | STIMULAN- CALCIUM SULFATE BONE VOID FILLER Encore Orthopedics, Inc. | MQV |
| Aug 11, 1998 | K980854 | RETROGRADE PEDIATRIC NAIL Encore Orthopedics, Inc. | HTY |
| Apr 16, 1998 | K980473 | PRESS-FIT STEM Encore Orthopedics, Inc. | LZO |
| Jan 28, 1998 | K974095 | FOUNDATION POROUS COATED FLARED RIM SHELL Encore Orthopedics, Inc. | LPH |
| Jan 28, 1998 | K974093 | FOUNDATION POROUS COATED HEMISPHERICAL SHELL Encore Orthopedics, Inc. | LPH |
| Jan 28, 1998 | K973119 | FOUNDATION POROUS ACETABULAR SYSTEM Encore Orthopedics, Inc. | LPH |
| Jan 12, 1998 | K974294 | ENCORE LINEAR POROUS COATED HIP Encore Orthopedics, Inc. | LPH |
| Jan 12, 1998 | K972791 | ENCORE LINEAR HIP Encore Orthopedics, Inc. | JDI |
| Jan 2, 1998 | K973809 | FOUNDATION FRACTURE STEM Encore Orthopedics, Inc. | JDI |
| Dec 19, 1997 | K973685 | REVELATION POROUS HIP STEM Encore Orthopedics, Inc. | LPH |
| Dec 18, 1997 | K973672 | FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA Encore Orthopedics, Inc. | JWH |
| Dec 18, 1997 | K973614 | FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES Encore Orthopedics, Inc. | KWL |
| Dec 2, 1997 | K973302 | FOUNDATION POROUS HIP STEM Encore Orthopedics, Inc. | LPH |
| Jun 27, 1997 | K965002 | ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND Encore Orthopedics, Inc. | LZO |
| May 5, 1997 | K964178 | PRESS-FIT HIP STEM Encore Orthopedics, Inc. | LWJ |
| Apr 2, 1997 | K970031 | FOUNDATION KNEE SYSTEM TIBIAL COMPONENT Encore Orthopedics, Inc. | JWH |
Newest 50 of 85.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||