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FDA 510(k)

EUROPA™ Pedicle Screw System

K-Number: K182970 · 2019-01-22

ApplicantMiRus, LLC
Decision Date2019-01-22
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 2019-01-22 under 510(k) number K182970. 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 2019-01-22. The listed applicant is MiRus, LLC. The 510(k) number is K182970.

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

EUROPA™ Pedicle Screw System received FDA 510(k) clearance on 2019-01-22, under 510(k) number K182970.

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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