Osteonics Corp. - FDA 510(k) Cleared Devices
178
Total
136
Cleared
0
Denied
178 devices
Cleared
Jun 15, 1993
OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS
Orthopedic
208d
Cleared
Apr 20, 1993
OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD
Orthopedic
159d
Cleared
Feb 12, 1993
OSTEONICS(R) 700 SERIES TOTAL KNEE MOD FEMOR COMP
Orthopedic
112d
Cleared
Oct 30, 1992
OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR
Orthopedic
101d
Cleared
Oct 20, 1992
OSTEONICS ZIRCONIA C-TAPER FEMORAL BEARING HEAD
Orthopedic
326d
Cleared
Aug 11, 1992
7000 SERIES TOTAL KNEE MODULAR COMPONENT CEMENT CA
Orthopedic
97d
Cleared
Aug 11, 1992
OSTRONCS HEMI-HIP STEM SERIES
Orthopedic
96d
Cleared
May 26, 1992
ACETABULAR DOME AND SCREW HOLE PLUGS
Orthopedic
90d
Cleared
May 15, 1992
OSTEONICS 7000 POSTERIOR STAB. TOTAL KNEE FEM. COM
Orthopedic
213d
Cleared
May 15, 1992
OSTEONICS 7000 SERIES TOTAL KNEE BONE AUGMENTATION
Orthopedic
100d
Cleared
Feb 14, 1992
7000 SERIES TOTAL KNEE PATELLAR COMPONENTS
Orthopedic
88d
Cleared
Feb 14, 1992
7000 SERIES MODULAR TIBIAL COMPONENTS
Orthopedic
87d
Cleared
Dec 20, 1991
PT II DISTAL CEMENT SPACER
Orthopedic
79d
Cleared
Nov 22, 1991
OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES
Orthopedic
88d
Cleared
Aug 16, 1991
OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C
Orthopedic
121d
Cleared
Aug 16, 1991
OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP
Orthopedic
60d
Cleared
Aug 13, 1991
OSTEONICS 7000 SERIES STAND TOTAL KNEE FEMOR COMP
Orthopedic
90d
Cleared
Jul 26, 1991
OSTEONICS(R) PRT HIP STEM SERIES
Orthopedic
88d
Cleared
Jul 01, 1991
OMNIFIT II EPF HIP STEM SERIES
Orthopedic
83d
Cleared
Jun 26, 1991
OSTEONICS ION IMPLANT MOD-ML UNIKNEE FEMORAL COMP
Orthopedic
90d
Cleared
Jun 19, 1991
OSTEONICS 7000 SERIES TOTAL KNEE TIBIAL COMPONENTS
Orthopedic
104d
Cleared
Jun 05, 1991
OSTEONICS ION IMPLANTED TOTAL KNEE FEMORAL COMP
Orthopedic
90d
Cleared
May 13, 1991
PS OMNIFIT NORMALIZED HIP STEM SERIES
Orthopedic
88d
Cleared
Apr 08, 1991
OSTEONICS(R) MID-SHAFT CEMENT SPACER
Orthopedic
63d
Cleared
Apr 05, 1991
OSTEONICS CDH HIP STEM
Orthopedic
31d
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