Osteonics Corp. - FDA 510(k) Cleared Devices
178
Total
136
Cleared
0
Denied
176 devices
Cleared
Apr 22, 1997
OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM
Orthopedic
78d
Cleared
Feb 28, 1997
HANSSON PIN SYSTEM
Orthopedic
84d
Cleared
Feb 28, 1997
OSTEONICS SCREW HOLE PLUGS
Orthopedic
72d
Cleared
Feb 11, 1997
OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY
Orthopedic
90d
Cleared
Feb 03, 1997
OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP
Orthopedic
143d
Cleared
Jan 27, 1997
OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)
Orthopedic
117d
Cleared
Jan 17, 1997
OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY
Orthopedic
80d
Cleared
Dec 19, 1996
OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION)
Orthopedic
78d
Cleared
Dec 09, 1996
HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM
Orthopedic
175d
Cleared
Aug 14, 1996
OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM
Orthopedic
71d
Cleared
Aug 13, 1996
OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
Orthopedic
76d
Cleared
Aug 08, 1996
SILKON STAINLESS STEEL CABLE SYSTEM
Orthopedic
66d
Cleared
Apr 09, 1996
OSTEONICS N2/VAC PACKAGING PROCESS
Orthopedic
133d
Cleared
Apr 04, 1996
OSTEONICS OFFSET HIP STEMS
Orthopedic
184d
Cleared
Mar 05, 1996
OSTEONICS SHOULDER HUMERAL COMPONENTS
Orthopedic
78d
Cleared
Feb 21, 1996
OSTEONICS N2/VAC PACKAGING PROCESS
Orthopedic
85d
Cleared
Jan 17, 1996
OSTEONICS SECUR-FIT HA PLUS HIP STEM SERIES
Orthopedic
289d
Cleared
Nov 30, 1995
OSTEONICS UNIPOLAR ENDO HEAD
Orthopedic
62d
Cleared
Nov 22, 1995
OSTEONICS SECUR-FIT HA PSL EXTRA ACETABULAR COMPONENT SYSTEM
Orthopedic
86d
Cleared
Sep 08, 1995
OSTEONICS SPINAL SYSTEM
Orthopedic
147d
Cleared
Sep 06, 1995
OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES
Orthopedic
148d
Cleared
Sep 01, 1995
OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
Orthopedic
129d
Cleared
Aug 14, 1995
OSTEONICS PS HEMI-HIP STEM SERIES
Orthopedic
734d
Cleared
Aug 14, 1995
OSTEONICS RESTORATION CEMENTED HIP STEM SERIES
Orthopedic
377d
Cleared
Aug 11, 1995
OSTEONICS SERIES 7000 TOTAL KNEE FULL TIBIAL BONE AUGEMENTATION BLOCKS & WEDGES
Orthopedic
107d
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