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FDA 510(k)

US SPINE FACET FIXATION SYSTEM

K-Number: K061041 · 2006-06-19

ApplicantUs Spine
Decision Date2006-06-19
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

US SPINE FACET FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Us Spine. It received FDA 510(k) clearance on 2006-06-19 under 510(k) number K061041. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the US SPINE FACET FIXATION SYSTEM?

US SPINE FACET FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2006-06-19. The listed applicant is Us Spine. The 510(k) number is K061041.

When did US SPINE FACET FIXATION SYSTEM receive FDA 510(k) clearance?

US SPINE FACET FIXATION SYSTEM received FDA 510(k) clearance on 2006-06-19, under 510(k) number K061041.

Who is the listed applicant for US SPINE FACET FIXATION SYSTEM?

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

What is the FDA product code for US SPINE FACET FIXATION SYSTEM?

The FDA product code for US SPINE FACET FIXATION 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 Us Spine 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.

K082801PHANTOM PLUS CAGE SYSTEMK081883MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEMK081296PREFERENCE PEDICLE SCREW SYSTEMK062785LTD POLYAXIAL FIXATION 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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