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510(k) K973309

Device
VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW
Applicant
VILEX, INC.
510(k) number
K973309
Product code
HWC  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1998-01-16
Date received
1997-09-03
Regulation
888.3040
Classification name
Screw, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ABRAHAM LAVI
Address
811 Rt. 51, Industrial Complex Bldg. 10 Large PA US 15025 15025

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HWC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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
K251555Ultra™ Compression Screw SystemPace Surgical2025-11-06

Legacy Summary#

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FDA Review#

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