FDA.report

510(k) K242415

Device
TMC Compression Implant System
Applicant
Treace Medical Concepts
510(k) number
K242415
Product code
JDR
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-06
Date received
2024-08-15
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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Brittany Grochala
Address
100 Palmetto Park Pl. Ponte Vedra FL US 32081 32081

FDA Registration Numbers

Source Documents

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

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