FDA.reportPublic FDA data

510(k) K190586

Device
Monster® Screw System
Applicant
Paragon 28, Inc.
510(k) number
K190586
Product code
HWC  
Decision
Substantially Equivalent (SESE)
Decision date
2019-04-03
Date received
2019-03-06
Regulation
888.3040
Classification name
Screw, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Eric Lintula
Address
4b Inverness Ct. E, Suite 280 Englewood CO US 80112 80112

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
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
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