K2m, Inc. - FDA 510(k) Cleared Devices
100
Total
97
Cleared
0
Denied
100 devices
Cleared
Mar 17, 2011
EVEREST SPINAL SYSTEM
Orthopedic
114d
Cleared
Mar 07, 2011
ALEUTTIAN
Orthopedic
131d
Cleared
Jan 13, 2011
CASPIAN SPINAL SYSTEM
Orthopedic
72d
Cleared
Oct 04, 2010
CASPIAN SPINAL SYSTEM
Orthopedic
168d
Cleared
Aug 02, 2010
RANGE SPINAL SYSTEM
Orthopedic
129d
Cleared
Jul 22, 2010
ALEUTIAN IBF SYSTEM
Orthopedic
73d
Cleared
Mar 11, 2010
PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS
Orthopedic
211d
Cleared
Mar 05, 2010
CHESAPEAKE SPINAL SYSTEM
Orthopedic
226d
Cleared
Feb 12, 2010
CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX
Orthopedic
32d
Cleared
Dec 16, 2009
MODIFICATION TO CASPIAN SPINAL SYSTEM
Orthopedic
30d
Cleared
Nov 06, 2009
CASPIAN SPINAL SYSTEM
Orthopedic
71d
Cleared
Jun 04, 2009
THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL,...
Orthopedic
36d
Cleared
Apr 21, 2009
ALEUTIAN IBF SYSTEM
Orthopedic
218d
Cleared
Mar 04, 2009
MESA SPINAL SYSTEM
Orthopedic
365d
Cleared
Dec 11, 2008
MESA AND RANGE SPINAL SYSTEMS
Orthopedic
80d
Cleared
Nov 19, 2008
THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS
Orthopedic
187d
Cleared
Oct 10, 2008
CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS
Orthopedic
175d
Cleared
Jun 13, 2008
RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
Orthopedic
28d
Cleared
Apr 08, 2008
K2M COCR ROD
Orthopedic
19d
Cleared
Mar 24, 2008
CAYMAN BUTTRESS PLATE SYSTEM
Orthopedic
48d
Cleared
Jan 24, 2008
ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01
Orthopedic
20d
Cleared
Jan 03, 2008
NATURAL BRIDGE LP TRANSVERSE CONNECTORS
Orthopedic
83d
Cleared
May 03, 2007
RANGE SPINAL SYSTEM
Orthopedic
99d
Cleared
Feb 23, 2007
ALEUTIAN SPACER SYSTEM
Orthopedic
106d
Cleared
Feb 14, 2007
MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM
Orthopedic
82d
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