FDA.report

510(k) K231458

Device
Extremity Staple
Applicant
Restor3D
510(k) number
K231458
Product code
JDR
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-03
Date received
2023-05-19
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
Anika Moorjani
Address
311 W. Corporation St. Durham NC US 27701 27701

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

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