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FDA 510(k)

M.U.S.T. Pedicle Screw System

K-Number: K153664 · 2016-01-19

ApplicantMedacta International
Decision Date2016-01-19
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M.U.S.T. Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International. It received FDA 510(k) clearance on 2016-01-19 under 510(k) number K153664. 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?

M.U.S.T. Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2016-01-19. The listed applicant is Medacta International. The 510(k) number is K153664.

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

M.U.S.T. Pedicle Screw System received FDA 510(k) clearance on 2016-01-19, under 510(k) number K153664.

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

The FDA 510(k) record lists Medacta International 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?

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

Related Clinical Trials

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.

NCT07790068Evaluation of Safety of Complex Pedicle Screw Trajectories Using Patient-Specific Guides (MySpine, Medacta)ACTIVE_NOT_RECRUITINGNCT07616895MFinity BE Pre-market TrialNOT_YET_RECRUITING

Other records listing Medacta International as applicant

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.

K261016MSS - Humeral reverse liners extensionK160605MectaLIF Anterior Stand-AloneK160289MasterLoc Stem

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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