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FDA 510(k)

M.U.S.T. Pedicle Screw System - Extension

K-Number: K253940 · 2026-04-28

ApplicantMedacta International S.A.
Decision Date2026-04-28
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M.U.S.T. Pedicle Screw System - Extension is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2026-04-28 under 510(k) number K253940. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M.U.S.T. Pedicle Screw System - Extension?

M.U.S.T. Pedicle Screw System - Extension is a medical device that received FDA 510(k) clearance on 2026-04-28. The listed applicant is Medacta International S.A.. The 510(k) number is K253940.

When did M.U.S.T. Pedicle Screw System - Extension receive FDA 510(k) clearance?

M.U.S.T. Pedicle Screw System - Extension received FDA 510(k) clearance on 2026-04-28, under 510(k) number K253940.

Who is the listed applicant for M.U.S.T. Pedicle Screw System - Extension?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M.U.S.T. Pedicle Screw System - Extension?

The FDA product code for M.U.S.T. Pedicle Screw System - Extension is NKB.

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Related Devices (Code: NKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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