FDA.reportPublic FDA data

510(k) K222820

Device
BRM TOOL Screws, BIOPLAN Subtalar Implant
Applicant
Brm Extremities
510(k) number
K222820
Product code
HWC
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-16
Date received
2022-09-19
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
No

Applicant Contact#

Contact
Lisa Fazzini
Address
Via Papa Giovanni Xxiii, 9 Civate IT 23862 23862

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
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
K260934TITAN Nail; APTUS K-Wire SystemMedartis AG2026-04-17
K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics2026-04-10
K253042Tyber Medical Trauma ScrewTyber Medical, LLC2026-04-03
K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip QuattroMedShape, Inc.2026-03-18
K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.2026-03-06
K252901Tyber Medical Trauma ScrewTyber Medical, LLC2025-12-31