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FDA 510(k)

RESOLUTE FACET SCREW SYSTEM

K-Number: K121551 · 2012-10-23

ApplicantNeurostructures, LLC
Decision Date2012-10-23
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

RESOLUTE FACET SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Neurostructures, LLC. It received FDA 510(k) clearance on 2012-10-23 under 510(k) number K121551. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESOLUTE FACET SCREW SYSTEM?

RESOLUTE FACET SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2012-10-23. The listed applicant is Neurostructures, LLC. The 510(k) number is K121551.

When did RESOLUTE FACET SCREW SYSTEM receive FDA 510(k) clearance?

RESOLUTE FACET SCREW SYSTEM received FDA 510(k) clearance on 2012-10-23, under 510(k) number K121551.

Who is the listed applicant for RESOLUTE FACET SCREW SYSTEM?

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

What is the FDA product code for RESOLUTE FACET SCREW SYSTEM?

The FDA product code for RESOLUTE FACET SCREW SYSTEM is MRW.

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Other records listing Neurostructures, LLC 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.

K131374TEMPUS(TM) CERVICAL PLATE SYSTEMK120515TEMPUS CERVICAL PLATE SYSTEM

Related Devices (Code: MRW)

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.

K262618Arthrex Spine Compression FT ScrewArthrex, Inc.K261209Ion-LSurGenTec, LLCK253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc.K253432DiversiVy™ Facet Screw SystemVy Spine, LLCK251714Ion-CSurGenTec, LLCK250679FFX Facet Fixation SystemSc Medica

Official Source

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

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