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FDA 510(k)

FACET FIXX

K-Number: K131417 · 2013-07-12

ApplicantNexxt Spine, LLC
Decision Date2013-07-12
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

FACET FIXX is the device name listed in this FDA 510(k) record. The listed applicant is Nexxt Spine, LLC. It received FDA 510(k) clearance on 2013-07-12 under 510(k) number K131417. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FACET FIXX?

FACET FIXX is a medical device that received FDA 510(k) clearance on 2013-07-12. The listed applicant is Nexxt Spine, LLC. The 510(k) number is K131417.

When did FACET FIXX receive FDA 510(k) clearance?

FACET FIXX received FDA 510(k) clearance on 2013-07-12, under 510(k) number K131417.

Who is the listed applicant for FACET FIXX?

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

What is the FDA product code for FACET FIXX?

The FDA product code for FACET FIXX is MRW.

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Other records listing Nexxt 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.

K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemK221905INERTIA CONNEXX Modular Pedicle Screw SystemK220291NEXXT SPINE NAVIGATION SystemK202230NEXXT MATRIXX Stand Alone ALIF SystemK202192STRUXXURE®-L and STRUXXURE®-A Plate SystemK200969NEXXT MATRIXX System

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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

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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