FDA.report

510(k) K252019

Device
CurvaFix Low Profile System
Applicant
Curvafix, Inc.
510(k) number
K252019
Product code
HWC
Decision
Substantially Equivalent (SESE)
Decision date
2025-08-29
Date received
2025-06-30
Regulation
888.3040
Classification name
Screw, 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
Mark Foster
Address
1406 140th Pl. NE Suite 107 Bellevue WA US 98007 98007

FDA Registration Numbers

Source Documents

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

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K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.2025-10-02
K251382Phoenix Sinus Tarsi Stent SystemAstra Orthomed, Inc.2025-08-27
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