FDA.report

510(k) K221342

Device
REDEMPTION Beaming System
Applicant
Vilex, LLC
510(k) number
K221342
Product code
HWC
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-13
Date received
2022-05-09
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
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Louis Monaco
Address
111 Moffitt St. Mcminnville TN US 37110 37110

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00841731131645REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131492REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131508REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131515REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131522REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131539REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131546REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131553REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131560REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131577REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131584REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131591REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131607REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131614REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131621REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131638REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131805REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131652REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131669REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131676REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131683REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131690REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131706REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131713REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131720REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131737REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131744REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131751REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131768REDEMPTION Beaming SystemVILEX LLC2024-03-08
00841731131775REDEMPTION Beaming SystemVILEX LLC2024-03-08

Other 510(k) Records For Product Code HWC

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