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510(k) K112837

Device
VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)
Applicant
VILEX, INC.
510(k) number
K112837
Product code
JDR  
Decision
Substantially Equivalent (SESE)
Decision date
2012-10-09
Date received
2011-09-28
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
No

Applicant Contact#

Contact
SYLVIA SOUTHARD
Address
111 Moffitt St. Mcminnville TN US 37110 37110

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JDR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261121Megalodon Dynamic Compression SystemParagon 28, Inc.2026-08-06
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
K231493NITINEX Memory Compression StapleVilex, LLC2023-08-11
K231885Medline UNITE® REFLEX® Nitinol Staple SystemMedline Industries, LP2023-08-09
K231458Extremity StapleRestor3D2023-08-03

Legacy Summary#

summary

FDA Review#

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