FDA.report

510(k) K252758

Device
Cannulated Screw and Kirschner (K wire) System
Applicant
Orthonovis, Inc.
510(k) number
K252758
Product code
HWC
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-02
Date received
2025-08-29
Regulation
888.3040
Classification name
Screw, 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
Ken West
Address
1 Hargrove Grade Suite 2f Palm Coast FL US 32137 32137

FDA Registration Numbers

Source Documents

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

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