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FDA 510(k)

Europa Pedicle Screw System

K-Number: K192268 · 2019-10-22

ApplicantMiRus, LLC
Decision Date2019-10-22
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Europa Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is MiRus, LLC. It received FDA 510(k) clearance on 2019-10-22 under 510(k) number K192268. 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 Europa Pedicle Screw System?

Europa Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2019-10-22. The listed applicant is MiRus, LLC. The 510(k) number is K192268.

When did Europa Pedicle Screw System receive FDA 510(k) clearance?

Europa Pedicle Screw System received FDA 510(k) clearance on 2019-10-22, under 510(k) number K192268.

Who is the listed applicant for Europa Pedicle Screw System?

The FDA 510(k) record lists MiRus, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Europa Pedicle Screw System?

The FDA product code for Europa Pedicle Screw System is NKB.

Other records listing MiRus, LLC 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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