FDA.reportPublic FDA data

510(k) K242436

Device
Proximal Humerus Fixation System
Applicant
Skeletal Dynamics, Inc.
510(k) number
K242436
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-14
Date received
2024-08-16
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
Alexandra Rodriguez Rojas
Address
7300 N. Kendall Dr. Suite 800 Miami FL US 33156 33156

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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