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510k Database
Manufacturers
US
Osseon, LLC
Medical Device Manufacturer
·
US , Santa Rosa , CA
Osseon, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2014
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Osseon, LLC
Orthopedic
✕
3
devices
1-3 of 3
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Cleared
Apr 09, 2015
Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml
K150607
·
NDN
Orthopedic
·
30d
Cleared
Aug 21, 2014
OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML
K141930
·
NDN
Orthopedic
·
36d
Cleared
Jun 19, 2014
OSSEOFLEX SB
K140937
·
NDN
Orthopedic
·
69d
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Orthopedic
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