K2m, Inc. - FDA 510(k) Cleared Devices
100
Total
97
Cleared
0
Denied
100 devices
Cleared
Oct 03, 2013
EVEREST SPINAL SYSTEM
Orthopedic
65d
Cleared
Aug 30, 2013
RANGE SPINAL SYSTEM
Orthopedic
73d
Cleared
May 30, 2013
ALEUTIAN SPINAL SYSTEM
Orthopedic
77d
Cleared
May 09, 2013
RANGE SPINAL SYSTEM
Orthopedic
27d
Cleared
May 08, 2013
RANGE SPINAL SYSTEM, SMALL STATURE
Orthopedic
231d
Cleared
May 02, 2013
RANGE SPINAL SYSTEM
Orthopedic
80d
Cleared
Feb 13, 2013
RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS
Orthopedic
99d
Cleared
Sep 11, 2012
RANGE SPINAL SYSTEM
Orthopedic
99d
Cleared
Jul 20, 2012
CASIAN, 3.5/4.5 CONNECTORS
Orthopedic
30d
Cleared
Jun 27, 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
Orthopedic
84d
Cleared
May 25, 2012
RANGE SPINAL SYSTEM, UNIT ROD
Orthopedic
60d
Cleared
May 18, 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
Orthopedic
127d
Cleared
Apr 04, 2012
EVEREST SPINAL SYSTEM
Orthopedic
30d
Cleared
Mar 16, 2012
CHESAPEAKE SPINAL SYSTEM
Orthopedic
72d
Cleared
Jan 27, 2012
SANTORINI SPINAL SYSTEM
Orthopedic
262d
Cleared
Jan 17, 2012
K2M, PYRENEES CERVICAL PLATE SYSTEM
Orthopedic
64d
Cleared
Jan 12, 2012
CASPIAN
Orthopedic
31d
Cleared
Jan 10, 2012
ALEUTIAN SYSTEM
Orthopedic
77d
Cleared
Dec 21, 2011
RANGE SPINAL SYSTEM (MESA AND DENALI)
Orthopedic
79d
Cleared
Oct 06, 2011
RANGE SPINAL SYSTEM (MESA AND DENALI)
Orthopedic
80d
Cleared
Aug 24, 2011
CHESAPEAKE (CERVICAL COMPONENTS)
Orthopedic
92d
Cleared
Aug 17, 2011
PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)
Orthopedic
117d
Cleared
Aug 02, 2011
MESA SPINAL SYSTEM (KEYSTONE RODS)
Orthopedic
116d
Cleared
Jun 22, 2011
ALEUTIAN SPACER SYSTEM
Orthopedic
89d
Cleared
May 20, 2011
K2M COCR WIRE
Orthopedic
144d
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