FDA.reportPublic FDA data

510(k) K234048

Device
M.U.S.T. Pedicle Screw System - Extension
Applicant
Medacta International S.A.
510(k) number
K234048
Product code
NKB
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-13
Date received
2023-12-21
Regulation
888.3070
Classification name
Thoracolumbosacral Pedicle Screw System
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Stefano Baj
Address
Strada Regina Castel San Pietro CH 6874 6874

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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