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FDA 510(k)

SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM

K-Number: K132126 · 2013-10-28

ApplicantSpectrum Spine, LLC
Decision Date2013-10-28
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Spine, LLC. It received FDA 510(k) clearance on 2013-10-28 under 510(k) number K132126. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM?

SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2013-10-28. The listed applicant is Spectrum Spine, LLC. The 510(k) number is K132126.

When did SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM receive FDA 510(k) clearance?

SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM received FDA 510(k) clearance on 2013-10-28, under 510(k) number K132126.

Who is the listed applicant for SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM?

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

What is the FDA product code for SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM?

The FDA product code for SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM is MRW.

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.

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Other records listing Spectrum Spine, 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.

K201024Expandable Titanium PLIF/TLIF SystemK173518Spectrum Spine Expandable Cages (SSEC)K122822SPECTRUM SPINE LAMINOPLASTY PLATING 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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