FDA.report

510(k) K253940

Device
M.U.S.T. Pedicle Screw System - Extension
Applicant
Medacta International S.A.
510(k) number
K253940
Product code
NKB
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-28
Date received
2025-12-09
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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

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

FDA Registration Numbers

Source Documents

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

Other 510(k) Records For Product Code NKB

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K254274ARx® SAI Implant SystemLife Spine, Inc.2026-04-16
K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026-04-03
K254247OSTEOMNI SPINAL FIXATION SYSTEMOsteomni, Inc.2026-02-24
K253169Duet™ Spinal Fixation SystemBox Spine, LLC2026-02-23
K253545Vulcan Spinal SystemK2m, Inc.2026-02-10
K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.2026-01-13
K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026-01-07
K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.2026-01-07
K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2025-12-17