FDA.report

510(k) K253042

Device
Tyber Medical Trauma Screw
Applicant
Tyber Medical, LLC
510(k) number
K253042
Product code
HWC
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-03
Date received
2025-09-22
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
Nicole Merlini
Address
83 S. Commerce Way, Suite 310 Bethlehem PA US 18017 18017

FDA Registration Numbers

Source Documents

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

Other 510(k) Records For Product Code HWC

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K252019CurvaFix Low Profile SystemCurvafix, Inc.2025-08-29
K251382Phoenix Sinus Tarsi Stent SystemAstra Orthomed, Inc.2025-08-27
K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC2025-08-15