FDA.reportPublic FDA data

510(k) K232693

Device
Tyber Medical Distal Radius Plating System
Applicant
Tyber Medical, LLC
510(k) number
K232693
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-04
Date received
2023-09-05
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Lisa Boyle
Address
83 S. Commerce Way Suite 310 Bethlehem PA US 18036 18036

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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