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FDA 510(k)

FIXCET SPINAL FACET SCREW SYSTEM

K-Number: K100154 · 2010-05-21

ApplicantX-Spine Systems, Inc.
Decision Date2010-05-21
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

FIXCET SPINAL FACET SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2010-05-21 under 510(k) number K100154. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIXCET SPINAL FACET SCREW SYSTEM?

FIXCET SPINAL FACET SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2010-05-21. The listed applicant is X-Spine Systems, Inc.. The 510(k) number is K100154.

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

FIXCET SPINAL FACET SCREW SYSTEM received FDA 510(k) clearance on 2010-05-21, under 510(k) number K100154.

Who is the listed applicant for FIXCET SPINAL FACET SCREW SYSTEM?

The FDA 510(k) record lists X-Spine Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIXCET SPINAL FACET SCREW SYSTEM?

The FDA product code for FIXCET SPINAL FACET SCREW SYSTEM is MRW.

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Other records listing X-Spine Systems, Inc. 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.

K173832InTice™-C Porous Ti Cervical Interbody SystemK180153X-spine Cortical Bone Screw SystemK170119Calix Lumbar Spinal Implant SystemK171567IRIX-A Lumbar Integrated Fusion SystemK171075Calix-C Cervical Interbody SpacerK170224Spider Cervical Plating 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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