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Fusion Orthopedics, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242091Bolo Button SystemDecember 23, 2024
K211843PolyLock Plating SystemMarch 4, 2022
K210159IntraLock SystemJuly 23, 2021
K193377TopLock Anchor SystemNovember 25, 2020
K202959PolyLock Plating SystemNovember 24, 2020
K192323PolyLock Small Bone Plating SystemNovember 18, 2019
K190136Fusion Silastic SystemOctober 21, 2019
K182342IntraLock Lapidus SystemMay 21, 2019
K182684HammerTechTM Fixation SystemNovember 23, 2018
K181815DynaBridgeOctober 15, 2018
K170624TalarLift STSAugust 11, 2017
K170038FuzeFix Screw SystemAugust 7, 2017
K161449HammerTech Fixation SystemOctober 11, 2016