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FDA 510(k)

zLOCK Lumbar Facet Fixation System

K-Number: K242650 · 2024-09-20

ApplicantZygofix , Ltd.
Decision Date2024-09-20
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

zLOCK Lumbar Facet Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Zygofix , Ltd.. It received FDA 510(k) clearance on 2024-09-20 under 510(k) number K242650. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the zLOCK Lumbar Facet Fixation System?

zLOCK Lumbar Facet Fixation System is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is Zygofix , Ltd.. The 510(k) number is K242650.

When did zLOCK Lumbar Facet Fixation System receive FDA 510(k) clearance?

zLOCK Lumbar Facet Fixation System received FDA 510(k) clearance on 2024-09-20, under 510(k) number K242650.

Who is the listed applicant for zLOCK Lumbar Facet Fixation System?

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

What is the FDA product code for zLOCK Lumbar Facet Fixation System?

The FDA product code for zLOCK Lumbar 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.

NCT07222787Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion OutcomesRECRUITING

Other records listing Zygofix , Ltd. 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.

K240085zLOCK Lumbar Facet 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.

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 MedicaK253190CORUS-LX ImplantProvidence Medical Technology, Inc.

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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