zLOCK Lumbar Facet Fixation System

FDA 510(k) K240085 · Zygofix , Ltd.

Substantially Equivalent

510(k) numberK240085

Submission

Device name
zLOCK Lumbar Facet Fixation System
Applicant
Zygofix , Ltd.
Misgav, IL
Received
January 11, 2024
Decision date
April 18, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MRW – System, Facet Screw Spinal Device
Device class
Unclassified
Implant
Yes

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More from Spinal Elements, Inc.

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Questions and answers

When was zLOCK Lumbar Facet Fixation System cleared by the FDA?

zLOCK Lumbar Facet Fixation System (K240085) received a 510(k) decision of Substantially Equivalent on April 18, 2024, 98 days after the submission was received.

What is the product code of K240085?

The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.