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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 a medical device manufactured by Zygofix , Ltd.. It received FDA 510(k) clearance on 2024-09-20 under approval 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. It is manufactured by Zygofix , Ltd.. The 510(k) number is K242650.

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

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

What company makes zLOCK Lumbar Facet Fixation System?

zLOCK Lumbar Facet Fixation System is manufactured by Zygofix , Ltd..

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

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07277803 Device-Based vs Manual Sensory Training in Low Back Pain NOT_YET_RECRUITING NCT06011551 HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs RECRUITING

Other Devices by Zygofix , Ltd.

K240085zLOCK Lumbar Facet Fixation System

Related Devices (Code: MRW)

K161798FacetBRIDGE® SystemLdr Spine USA, Inc. K152137FacetBRIDGE SystemLdr Spine USA K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc. K180729FaSet Fixation SystemHuvexel Co. , Ltd. K173198Facet Screw Fixation SystemU&I Corporation K192744CORRIDOR Fixation SystemGlobus Medical, Inc.

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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