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FDA 510(k)

M.U.S.T. Pedicle Screw Extension and Long Tab Implants

K-Number: K203482 · 2021-01-26

ApplicantMedacta International S.A.
Decision Date2021-01-26
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M.U.S.T. Pedicle Screw Extension and Long Tab Implants 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 2021-01-26 under 510(k) number K203482. 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 Extension and Long Tab Implants?

M.U.S.T. Pedicle Screw Extension and Long Tab Implants is a medical device that received FDA 510(k) clearance on 2021-01-26. The listed applicant is Medacta International S.A.. The 510(k) number is K203482.

When did M.U.S.T. Pedicle Screw Extension and Long Tab Implants receive FDA 510(k) clearance?

M.U.S.T. Pedicle Screw Extension and Long Tab Implants received FDA 510(k) clearance on 2021-01-26, under 510(k) number K203482.

Who is the listed applicant for M.U.S.T. Pedicle Screw Extension and Long Tab Implants?

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 Extension and Long Tab Implants?

The FDA product code for M.U.S.T. Pedicle Screw Extension and Long Tab Implants is NKB.

Other records listing Medacta International S.A. as applicant

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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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