FDA.reportPublic FDA data

FUSION ORTHOPEDICS USA, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30133658023013365802FUSION ORTHOPEDICS USA, LLC1Y2026-01-016859 E Rembrandt Ave Ste 122 Mesa AZ US 85212

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2006281132272426K922292LUNDEEN SUBTALAR PEG IMPLANTMJW1992-10-23
2006281783880843K905795SGARLATO FLEXIBLE HINGE TOE IMPLANTKWH1991-05-29
2006281962692790K884739SGARLATO LESSER TOE IMPLANTKWH1989-05-18
2006281604055200K252961Fusion FibFix NailHSB2026-03-18
2006281914083601K242091Bolo Button SystemHTN2024-12-23
2006281812706725K233025Revolution External Plating SystemKTT2024-05-30
2006281424207690K223114Suture Anchors - HTA Headless Titanium Anchor and Zip AnchorsMBI2023-08-02
2006281111879947K211843PolyLock Plating SystemHRS2022-03-04
2006281520625447K202959PolyLock Plating SystemHRS2020-11-24
2006281233054327K193377TopLock Anchor SystemMBI2020-11-25
2006281890190255K192323PolyLock Small Bone Plating SystemHRS2019-11-18
2006281510725265K190136Fusion Silastic SystemKWH2019-10-21
2006281309562469K182684HammerTechTM Fixation SystemHWC2018-11-23
2006281754971022K182342IntraLock Lapidus SystemHWC2019-05-21
2006281797640127K181815DynaBridgeJDR2018-10-15
2006281469326804K181630Revolution External Plating SystemKTT2019-05-29
2006281504715960K170624TalarLift STSHWC2017-08-11
2006281750212076K170038FuzeFix Screw SystemHWC2017-08-07
2006281758856641K161449HammerTech Fixation SystemHWC2016-10-11
2006281318360374
2006281713107964
2006281823095211
2006281858016641

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HWC52019-05-21
HRS32022-03-04
KWH32019-10-21
KTT22024-05-30
MBI22023-08-02
HSB12026-03-18
HTN12024-12-23
JDR12018-10-15
MJW11992-10-23