Medical Device Manufacturer · US , Draper , UT

Ortho Development Corp. - FDA 510(k) Cleared Devices

45 submissions · 43 cleared · Since 1996
45
Total
43
Cleared
0
Denied
45 devices
26-45 of 45
Cleared Jul 07, 2005
PIVOT BIPOLAR FEMORAL HEAD
K050966 · KWY
Orthopedic · 80d
Cleared Apr 11, 2005
ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER
K042565 · LPH
Orthopedic · 202d
Cleared Jan 27, 2005
SOLITUDE UNIPOLAR HEAD
K042973 · KWL
Orthopedic · 91d
Cleared Jul 15, 2003
ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM
K031201 · JWH
Orthopedic · 90d
Cleared May 06, 2002
ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED
K020383 · JWH
Orthopedic · 90d
Cleared Apr 05, 2002
ENVISION ANTERIOR CERVICAL PLATE SYSTEM
K020649 · KWQ
Orthopedic · 36d
Cleared Aug 22, 2001
ORTHO DEVELOPMENT ORION-I EMF SYSTEM
K012129 · GEI
General & Plastic Surgery · 44d
Cleared Apr 10, 2000
HEMISPHERE MODULAR CUP SYSTEM
K000321 · LPH
Orthopedic · 68d
Cleared Mar 24, 2000
ORTHO DEVELOPMENT BALANCED KNEE SYSTEM
K994370 · JWH
Orthopedic · 88d
Cleared Oct 14, 1999
CONTOUR SPINAL SYSTEM
K990986 · KWP
Orthopedic · 204d
Cleared Oct 07, 1998
ODC B2 BIPOLAR CUP
K982389 · KWY
Orthopedic · 90d
Cleared Dec 09, 1997
ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY
K974158 · KNW
Gastroenterology & Urology · 36d
Cleared Aug 22, 1997
HEADLOC CERAMIC HEAD
K970675 · LZO
Orthopedic · 179d
Cleared Jul 18, 1997
HEMISPHERE CEMENTED CUP
K971581 · JDI
Orthopedic · 79d
Cleared Jul 09, 1997
HEADLOC CERAMIC HEAD
K971426 · LZO
Orthopedic · 83d
Cleared Jul 09, 1997
HEADLOC CERAMIC FEMORAL HEADS
K971435 · LZO
Orthopedic · 82d
Cleared Sep 19, 1996
PRIMALOC CEMENTED HIP SYSTEM
K962448 · KWY
Orthopedic · 87d
Cleared Jul 26, 1996
BI-LOC BIPOLAR CUP
K961793 · KWY
Orthopedic · 78d
Cleared May 08, 1996
HEMISPHERE ACETABULAR CUP
K960660 · LPH
Orthopedic · 82d
Cleared Jan 26, 1996
PRIMALOC CEMENTLESS HIP SYSTEM
K953977 · KWY
Orthopedic · 156d
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