Medical Device Manufacturer · US , Red Rock , TX

Encore Orthopedics, Inc. - FDA 510(k) Cleared Devices

85 submissions · 74 cleared · Since 1993
85
Total
74
Cleared
0
Denied
84 devices
26-50 of 84
Cleared Aug 12, 1999
ULTIMAX HAIG II NAIL SYSTEM
K991889 · LXT
Orthopedic · 70d
Cleared Aug 12, 1999
ENCORE FULLY COATED HIP
K992109 · LPH
Orthopedic · 51d
Cleared Aug 06, 1999
ULTIMAX ANKLE FUSION ROD SYSTEM
K991790 · HSB
Orthopedic · 72d
Cleared Jun 29, 1999
GRIT BLASTED HUMERAL STEM
K991603 · KWT
Orthopedic · 50d
Cleared Jun 25, 1999
MODIFICATION OF ENCORE LINEAR POROUS COATED HIP
K991325 · LPH
Orthopedic · 67d
Cleared Jun 01, 1999
FOUNDATION POROUS HIP STEM
K991226 · LZO
Orthopedic · 50d
Cleared Jun 01, 1999
8MM FORGED CEMENTED STEM
K991227 · JDI
Orthopedic · 50d
Cleared Mar 17, 1999
HINGED KNEE
K982160 · KRO
Orthopedic · 271d
Cleared Feb 26, 1999
STIMULAN- CALCIUM SULFATE BONE VOID FILLER
K982663 · MQV
Orthopedic · 211d
Cleared Aug 11, 1998
RETROGRADE PEDIATRIC NAIL
K980854 · HTY
Orthopedic · 159d
Cleared Apr 16, 1998
PRESS-FIT STEM
K980473 · LZO
Orthopedic · 69d
Cleared Jan 28, 1998
FOUNDATION POROUS ACETABULAR SYSTEM
K973119 · LPH
Orthopedic · 161d
Cleared Jan 28, 1998
FOUNDATION POROUS COATED HEMISPHERICAL SHELL
K974093 · LPH
Orthopedic · 90d
Cleared Jan 28, 1998
FOUNDATION POROUS COATED FLARED RIM SHELL
K974095 · LPH
Orthopedic · 90d
Cleared Jan 12, 1998
ENCORE LINEAR HIP
K972791 · JDI
Orthopedic · 168d
Cleared Jan 12, 1998
ENCORE LINEAR POROUS COATED HIP
K974294 · LPH
Orthopedic · 59d
Cleared Jan 02, 1998
FOUNDATION FRACTURE STEM
K973809 · JDI
Orthopedic · 88d
Cleared Dec 19, 1997
REVELATION POROUS HIP STEM
K973685 · LPH
Orthopedic · 84d
Cleared Dec 18, 1997
FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES
K973614 · KWL
Orthopedic · 86d
Cleared Dec 18, 1997
FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA
K973672 · JWH
Orthopedic · 83d
Cleared Dec 02, 1997
FOUNDATION POROUS HIP STEM
K973302 · LPH
Orthopedic · 90d
Cleared Jun 27, 1997
ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS...
K965002 · LZO
Orthopedic · 193d
Cleared May 05, 1997
PRESS-FIT HIP STEM
K964178 · LWJ
Orthopedic · 199d
Cleared Apr 02, 1997
FOUNDATION KNEE SYSTEM TIBIAL COMPONENT
K970031 · JWH
Orthopedic · 89d
Cleared Mar 13, 1997
TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM
K961360 · HSB
Orthopedic · 338d

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