ClearanceBrief
Company ยท US

Fusion Orthopedics, LLC

FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.

14510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
HWCScrew, Fixation, Bone6
HRSPlate, Fixation, Bone3
HSBRod, Fixation, Intramedullary And Accessories1
HTNWasher, Bolt Nut1
JDRStaple, Fixation, Bone1
KWHProsthesis, Toe, Constrained, Polymer1
MBIFastener, Fixation, Nondegradable, Soft Tissue1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Mar 18, 2026K252961Fusion FibFix Nail
Fusion Orthopedics USA, LLC
HSB
Dec 23, 2024K242091Bolo Button System
Fusion Orthopedics
HTN
Mar 4, 2022K211843PolyLock Plating System
Fusion Orthopedics
HRS
Jul 23, 2021K210159IntraLock System
Fusion Orthopedics, LLC
HWC
Nov 25, 2020K193377TopLock Anchor System
Fusion Orthopedics, LLC
MBI
Nov 24, 2020K202959PolyLock Plating System
Fusion Orthopedics, LLC
HRS
Nov 18, 2019K192323PolyLock Small Bone Plating System
Fusion Orthopedics, LLC
HRS
Oct 21, 2019K190136Fusion Silastic System
Fusion Orthopedics, LLC
KWH
May 21, 2019K182342IntraLock Lapidus System
Fusion Orthopedics, LLC
HWC
Nov 23, 2018K182684HammerTechTM Fixation System
Fusion Orthopedics, LLC
HWC
Oct 15, 2018K181815DynaBridge
Fusion Orthopedics, LLC
JDR
Aug 11, 2017K170624TalarLift STS
Fusion Orthopedics, LLC
HWC
Aug 7, 2017K170038FuzeFix Screw System
Fusion Orthopedics, LLC
HWC
Oct 11, 2016K161449HammerTech Fixation System
Fusion Orthopedics, LLC
HWC

Latest recalls

DateFirm and productCodeLinked 510(k)
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