FDA.reportPublic FDA data

510(k) K232324

Device
StealthFix Intraosseous Fixation System
Applicant
Medartis, Inc.
510(k) number
K232324
Product code
JDR
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-30
Date received
2023-08-03
Regulation
888.3030
Classification name
Staple, 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
Chelsea Kozior
Address
1195 Polk Dr. Warsaw IN US 46582 46582

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
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
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
K230550JAWS Nitinol Staple SystemParagon 28, Inc.2023-05-11
K223056JAWS Nitinol Staple SystemParagon 28, Inc.2023-02-16