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
85 devices
51-75 of 85
Cleared Mar 13, 1997
TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM
K961360 · HSB
Orthopedic · 338d
Cleared Jan 27, 1997
METAL BACKED ACETABULAR COMPONENT
K963998 · LPH
Orthopedic · 112d
Cleared Jan 14, 1997
METAL ACETABULAR COMPONENT
K964227 · LPH
Orthopedic · 83d
Cleared Dec 27, 1996
FOUNDATION KNEE SYSTEM
K964008 · JWH
Orthopedic · 81d
Cleared Oct 01, 1996
PRESS-FIT FLARED SHELL
K960633 · LWJ
Orthopedic · 230d
Cleared Oct 01, 1996
TIBIAL INSERT
K963028 · JWH
Orthopedic · 57d
Cleared Sep 19, 1996
VITALITY HIP STEM
K962560 · JDI
Orthopedic · 80d
Cleared Sep 17, 1996
PRESS-FIT POROUS SHELL
K961526 · LPH
Orthopedic · 148d
Cleared Aug 09, 1996
FOUNDATION FORGED, TEXTURED & POROUS STEMS W/BIOLOX CERAMIC HEADS
K955563 · LPH
Orthopedic · 247d
Cleared Jun 14, 1996
FOUNDATION 9MM FORGED CEMENTED STEM
K961890 · JDI
Orthopedic · 30d
Cleared May 16, 1996
BERLIN EXTERNAL FIXATOR
K954053 · LXT
Orthopedic · 261d
Cleared May 03, 1996
DDS SPINAL SYSTEM
K960107 · MNH
Orthopedic · 113d
Cleared Apr 15, 1996
FOUNDATION GLENOID COMPONENT
K960906 · KWS
Orthopedic · 41d
Cleared Aug 09, 1995
HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS
K953510 · KWY
Orthopedic · 14d
Cleared Jul 17, 1995
FORGED CEMENTED STEM
K952191 · JDI
Orthopedic · 69d
Cleared Jul 17, 1995
FOUNDATION TEXTURED STEM
K952297 · LWJ
Orthopedic · 62d
Cleared Jul 13, 1995
GLIDING NAIL
K951809 · KTT
Orthopedic · 86d
Cleared Jul 11, 1995
FOUNDATION POROUS STEM
K935263 · JDI
Orthopedic · 615d
Cleared May 30, 1995
TOTAL SHOULDER PROSTHESIS
K950651 · KWS
Orthopedic · 106d
Cleared May 25, 1995
METAL BACKED ACETABULAR COMPONENT
K950542 · JDL
Orthopedic · 107d
Cleared May 22, 1995
HEMI-SHOULDER PROSTHESIS
K950594 · HSD
Orthopedic · 102d
Cleared Mar 30, 1995
FOUNDATION NON-POROUS STEM
K935449 · JDI
Orthopedic · 503d
Cleared Feb 14, 1995
CCG CERCLAGE SYSTEM
K932024 · JDQ
Orthopedic · 659d
Cleared Feb 08, 1995
FOUNDATION KNEE AUGMENTATION BLOCKS
K941306 · JWH
Orthopedic · 328d
Cleared Nov 08, 1994
FOUNDATION POSTERIOR STABILIZED KNEE
K933539 · JWH
Orthopedic · 475d

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