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510k Database
Manufacturers
US
K2m, Incorporated
Medical Device Manufacturer
·
US , Leesburg , VA
K2m, Incorporated - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2015
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - K2m, Incorporated
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 21, 2016
EVEREST Spinal System
K161369
·
NKB
Orthopedic
·
65d
Cleared
Feb 16, 2016
Caspian OCT/MESA Mini/DENALI Mini Spinal System
K153370
·
NKG
Orthopedic
·
85d
Cleared
Nov 17, 2015
RANGE/DENALI/MESA Spinal System
K153031
·
NKB
Orthopedic
·
29d
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Orthopedic
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