FDA.report

510(k) K231493

Device
NITINEX Memory Compression Staple
Applicant
Vilex, LLC
510(k) number
K231493
Product code
JDR
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-11
Date received
2023-05-23
Regulation
888.3030
Classification name
Staple, 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
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

Related GUDID Devices

Primary DIBrandCompanyPublished
00841731139566NITINEXVILEX LLC2024-12-05
00841731137326NITINEXVILEX LLC2024-12-05
00841731137340NITINEXVILEX LLC2024-12-05
00841731137357NITINEXVILEX LLC2024-12-05
00841731137371NITINEXVILEX LLC2024-12-05
00841731137432NITINEXVILEX LLC2024-12-05
00841731137463NITINEXVILEX LLC2024-12-05
00841731137500NITINEXVILEX LLC2024-12-05
00841731137531NITINEXVILEX LLC2024-12-05
00841731138019NITINEXVILEX LLC2024-12-05
00841731139962NITINEXVILEX LLC2024-12-05
00841731139887NITINEXVILEX LLC2024-12-05
00841731139894NITINEXVILEX LLC2024-12-05
00841731139900NITINEXVILEX LLC2024-12-05
00841731139917NITINEXVILEX LLC2024-12-05
00841731139924NITINEXVILEX LLC2024-12-05
00841731139931NITINEXVILEX LLC2024-12-05
00841731139948NITINEXVILEX LLC2024-12-05
00841731139955NITINEXVILEX LLC2024-12-05

Other 510(k) Records For Product Code JDR

510(k)DeviceApplicantDecision date
K250712Linkt Compression Staple SystemTrax Surgical2025-05-14
K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP2025-04-11
K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.2025-01-31
K243658TMC Compression Implant SystemTreace Medical Concepts2024-12-26
K242415TMC Compression Implant SystemTreace Medical Concepts2024-09-06
K240212COGNiTiON™ Staple SystemOrtho Solutions UK , Ltd.2024-02-23
K232990A’TOMIC™ Nitinol Fixation SystemRmr Ortho, LLC2024-01-12
K230724arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesNovastep2023-12-04
K232905Medline UNITE® REFLEX® Nitinol Staple KitMedline Industries, LP2023-10-19
K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.2023-08-30
K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts2023-08-28
K231885Medline UNITE® REFLEX® Nitinol Staple SystemMedline Industries, LP2023-08-09
K231458Extremity StapleRestor3D2023-08-03
K230550JAWS Nitinol Staple SystemParagon 28, Inc.2023-05-11
K223056JAWS Nitinol Staple SystemParagon 28, Inc.2023-02-16