Product code HWC

Current FDA Classification

Device name
Screw, Fixation, Bone
Medical specialty
Orthopedic
Device class
2
Regulation number
888.3040
Review panel
OR
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible

Related 510(k) Records

510(k)DeviceApplicantDecision date
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
K251555Ultra™ Compression Screw SystemPace Surgical2025-11-06
K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev42025-10-10
K250536MetaFore Small Screw SystemExtremity Medical, LLC2025-10-08
K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.2025-10-02
K252019CurvaFix Low Profile SystemCurvafix, Inc.2025-08-29
K251382Phoenix Sinus Tarsi Stent SystemAstra Orthomed, Inc.2025-08-27
K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC2025-08-15
K250251Eleganz Fusion Screw System (Fusion Screw System)Dev42025-06-13
K243943TriMed® Compression ScrewsTriMed, Inc.2025-04-10
K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.2025-04-02
K250304TITANEX Screw SystemsVilex, LLC2025-03-05
K242896Caliber Intramedullary Fixation SystemNvision Biomedical Technologies2025-02-05
K242442Quick-Start Orthopaedic Fixation Screw and Reverse Thread ScrewInnovate Orthopaedics, Ltd.2025-01-31
K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.2025-01-10
K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.2024-12-04
K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho2024-11-22
K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE)Tigon Medical2024-10-29
K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies2024-10-09
K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.2024-10-04
K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.2024-08-31
K241359Medline UNITE® MIS Foot Recon Screw SystemMedline Industries, LP2024-08-02

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