K2m, Inc. - FDA 510(k) Cleared Devices
100
Total
97
Cleared
0
Denied
100 devices
Cleared
Jul 22, 2016
K2M Growing Spine System
Orthopedic
101d
Cleared
Mar 18, 2016
NILE Alternative Fixation Spinal System
Orthopedic
50d
Cleared
Dec 21, 2015
Sahara Stabilization System
Orthopedic
202d
Cleared
Sep 17, 2015
Everest Spinal System
Orthopedic
83d
Cleared
Sep 04, 2015
Pyrenees Cervical Plate System
Orthopedic
45d
Cleared
Aug 20, 2015
Cascadia Interbody System
Orthopedic
177d
Cleared
Aug 10, 2015
Everest Spinal System
Orthopedic
96d
Cleared
May 07, 2015
Chesapeake Stabilization System
Orthopedic
245d
Cleared
May 01, 2015
Pyrenees Cervical Plate System
Orthopedic
262d
Cleared
Mar 31, 2015
Range/Denali/Mesa Spinal System
Orthopedic
50d
Cleared
Feb 25, 2015
Nile Alternative Fixation
Orthopedic
93d
Cleared
Jan 21, 2015
Everest Spinal System
Orthopedic
149d
Cleared
Jan 09, 2015
Range/Denali/Mesa Spinal System
Orthopedic
50d
Cleared
Nov 06, 2014
CAPRI
Orthopedic
104d
Cleared
Sep 08, 2014
RANGE/MESA/DENALI SPINAL SYSTEM
Orthopedic
59d
Cleared
Jul 30, 2014
K2M MODULAR HOOKS
Orthopedic
266d
Cleared
Jul 23, 2014
CASPIAN SPINAL SYSTEM
Orthopedic
68d
Cleared
Jul 10, 2014
RANGE/MESA/DENALI SPINAL SYSTEM
Orthopedic
105d
Cleared
Jul 01, 2014
CASPIAN OCT SPINAL SYSTEM
Orthopedic
249d
Cleared
Jun 10, 2014
CHESAPEAKE SPINAL SYSTEM
Orthopedic
208d
Cleared
Jun 03, 2014
RANGE SPINAL SYSTEM
Orthopedic
29d
Cleared
Apr 03, 2014
ALEUTIAN IBF SYSTEM
Orthopedic
129d
Cleared
Mar 21, 2014
RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM
Orthopedic
88d
Cleared
Nov 20, 2013
EVEREST SPINAL SYSTEM
Orthopedic
77d
Cleared
Nov 09, 2013
CAYMAN MI PLATE SYSTEM
Orthopedic
168d
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