Osteonics Corp. - FDA 510(k) Cleared Devices
178
Total
136
Cleared
0
Denied
178 devices
Cleared
Apr 01, 1991
OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES
Orthopedic
83d
Cleared
Mar 26, 1991
OSTEONICS ION IMPLANTED FEMORAL BEARING SERIES
Orthopedic
19d
Cleared
Jan 28, 1991
OSTEONICS(R) MPSS HIP STEM SERIES
Orthopedic
66d
Cleared
Jan 04, 1991
OSTEONICS(R) 6011 HIP STEM SERIES
Orthopedic
49d
Cleared
Jan 04, 1991
OSTEONICS HIP REVISION WEDGES
Orthopedic
32d
Cleared
Dec 20, 1990
THE OMNIFIT EPF HIP JOINT FEMORAL STEM
Orthopedic
428d
Cleared
Oct 30, 1990
OSTEONICS DRM ACETABULAR COMPONENT
Orthopedic
78d
Cleared
Aug 09, 1990
OSTEONICS PS HEAD AND NECK HIP STEM SERIES
Orthopedic
50d
Cleared
Apr 18, 1990
MC2P ACETABULAR COMPONENT
Orthopedic
78d
Cleared
Mar 21, 1990
OSTEONICS ECSI HIP STEM SERIES
Orthopedic
27d
Cleared
Mar 06, 1990
OSTEONICS CEMENT RESTRICTOR
Orthopedic
34d
Cleared
Feb 06, 1990
MOD-ML UNICOMPARTMENTAL KNEE PROSTHESIS
Orthopedic
63d
Cleared
Nov 03, 1989
KDR ACETABULAR COMPONENT
Orthopedic
42d
Cleared
Oct 12, 1989
OMNIFIT CERAMIC MORSE TAPER HEAD
Orthopedic
80d
Cleared
Oct 10, 1989
PT DISTAL TIP CEMENT SPACER
Orthopedic
78d
Cleared
Sep 11, 1989
OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS
Orthopedic
91d
Cleared
Jun 22, 1989
OMNIFIT CERAMIC MORSE TAPER HEAD (1002 SERIES)
Orthopedic
192d
Cleared
Jun 06, 1989
KDG ACETABULAR COMPONENT
Orthopedic
90d
Cleared
Apr 07, 1989
OMNIFIT CONSTRAINED ACETABULAR BEARING INSERT
Orthopedic
80d
Cleared
Mar 13, 1989
OMNIFIT UHMWPE ACETABULAR SHELL CEMENT SPACE SYST.
Orthopedic
33d
Cleared
Jan 18, 1989
OMNIFIT TOTAL KNEE SERIES III,IV & POST. STAB. FEM
Orthopedic
90d
Cleared
Jan 17, 1989
OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS
Orthopedic
90d
Cleared
Nov 10, 1988
SHOULDER MICROSTRUCTURED HUMERAL PROSTHESIS
Orthopedic
63d
Cleared
Oct 13, 1988
OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATING
Orthopedic
27d
Cleared
Aug 30, 1988
NORMAL HUMERAL PROSTHESIS
Orthopedic
127d
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