FDA.reportPublic FDA data

510(k) K254280

Device
F.A.S.T Screw
Applicant
Steps Ortho
510(k) number
K254280
Product code
HWC
Decision
Substantially Equivalent (SESE)
Decision date
2026-09-21
Date received
2025-12-30
Regulation
888.3040
Classification name
Screw, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Morgane Grenier
Address
3 Allée Des Ginkgos Bron FR 69500 69500

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HWC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies2026-10-14
K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies2026-10-02
K262975Arthrex Beaming SystemArthrex, Inc.2026-09-25
K260995DynaNail Helix® Fixation SystemMedShape, Inc.2026-09-23
K261057ActivaScrew™ Cannulated COMBioretec, Ltd.2026-09-04
K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped2026-08-24
K262344Large Compression ScrewsTriMed, Inc.2026-08-12
K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.2026-08-05
K262075Lapidus Screw KitRelja Innovations, LLC2026-07-22
K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.2026-06-25
K253108VEOFIX Snap Off ScrewSteps Ortho2026-06-05
K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC2026-05-30
K261241TriMed Compression ScrewsTriMed, Inc.2026-05-14
K254215Arthrex Beaming SystemArthrex, Inc.2026-05-08
K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO , Ltd.2026-05-01