FDA.reportPublic FDA data

510(k) K243050

Device
TriMed Posterior Malleolus Fixation System
Applicant
TriMed, Inc.
510(k) number
K243050
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-26
Date received
2024-09-27
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
Divya Raghavi Nandakumar
Address
27533 Ave. Hopkins Santa Clarita CA US 91355 91355

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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