Fusion Orthopedics, LLC is one of 16313 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Fusion Orthopedics, LLC - FDA 510(k) Cleared Devices
Recent clearances: IntraLock System, TopLock Anchor System, PolyLock Plating System
11
Total
11
Cleared
0
Denied
Fusion Orthopedics, LLC has 11 FDA 510(k) cleared orthopedic devices. Based in Mesa, US.
Last cleared in 2021. Active since 2016.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by The OrthoMedix Group, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Fusion Orthopedics, LLC
11 devices
Cleared
Jul 23, 2021
IntraLock System
Orthopedic
183d
Cleared
Nov 25, 2020
TopLock Anchor System
Orthopedic
356d
Cleared
Nov 24, 2020
PolyLock Plating System
Orthopedic
55d
Cleared
Nov 18, 2019
PolyLock Small Bone Plating System
Orthopedic
83d
Cleared
Oct 21, 2019
Fusion Silastic System
Orthopedic
265d
Cleared
May 21, 2019
IntraLock Lapidus System
Orthopedic
266d
Cleared
Nov 23, 2018
HammerTechTM Fixation System
Orthopedic
58d
Cleared
Oct 15, 2018
DynaBridge
Orthopedic
98d
Cleared
Aug 11, 2017
TalarLift STS
Orthopedic
162d
Cleared
Aug 07, 2017
FuzeFix Screw System
Orthopedic
214d
Cleared
Oct 11, 2016
HammerTech Fixation System
Orthopedic
139d