FDA.report

510(k) K260900

Device
DYNEX® External Fixation Systems
Applicant
Vilex, LLC
510(k) number
K260900
Product code
KTT
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-17
Date received
2026-03-18
Regulation
888.3030
Classification name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Brock Johnson
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

Other 510(k) Records For Product Code KTT

510(k)DeviceApplicantDecision date
K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.2026-03-23
K253291Excelsior SystemBlue Ocean Global2026-01-20
K253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.2025-12-19
K253202Hoffmann LRF SystemStryker GmbH2025-12-19
K252555Medusa Orthopedics Boa External Fixation SystemMedusa Orthopedics, LLC2025-11-25
K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC2025-11-20
K252106External Fixation Mini Rail SystemParagon 28, Inc.2025-09-30
K251862External Fixation Bone DistractorParagon 28, Inc.2025-08-11
K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.2025-08-08
K251128Extremity Medical External Fixation SystemExtremity Medical, LLC2025-05-07
K243798Orthex External Fixation SystemOrthoPediatrics Corp.2025-03-07
K241563Extremity Medical External Fixation SystemExtremity Medical, LLC2025-02-21
K242861TrueLok ElevateOrthofix Srl2024-12-03
K242452Monkey Bars Pin to Bar External Fixation SystemParagon 28, Inc.2024-11-01
K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC2024-09-18