Medical Device Manufacturer · US , Santa Rosa , CA

Osseon, LLC - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2014

Recent clearances: Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml, OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML, OSSEOFLEX SB

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Osseon, LLC Orthopedic ✕

3 devices

1-3 of 3

Cleared Apr 09, 2015

Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml

Orthopedic · 30d

Cleared Aug 21, 2014

OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML

Orthopedic · 36d

Cleared Jun 19, 2014

Orthopedic · 69d