FDA.report

510(k) K240085

Device
zLOCK Lumbar Facet Fixation System
Applicant
Zygofix , Ltd.
510(k) number
K240085
Product code
MRW
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-18
Date received
2024-01-11
Classification name
System, Facet Screw Spinal Device
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Ofer Levy
Address
17 Tchelet St. Misgav IL 2017900 2017900

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
07290019421160zLOCK tools Trays #1+ #3 ZYGOFIX LTD2024-10-20
07290019421153zLOCK tools Trays #1+ #2 ZYGOFIX LTD2024-10-20
07290019421146zLOCK tools Tray #3 ZYGOFIX LTD2024-10-20
07290019421139zLOCK tools Tray #2 ZYGOFIX LTD2024-10-20
07290019421122zLOCK tools Tray #1ZYGOFIX LTD2024-10-20
07290019421238Facet screw ZYGOFIX LTD2024-09-05
07290019421221zLOCK 4.0mm ZYGOFIX LTD2024-09-05
07290019421214zLOCK 3.5mm ZYGOFIX LTD2024-09-05
07290019421207zLOCK 3.0mm ZYGOFIX LTD2024-09-05
07290019421191zLOCK 2.5mm ZYGOFIX LTD2024-09-05
07290019421184zLOCK 2.0mm ZYGOFIX LTD2024-09-05
07290019421177zLOCK 1.5mm ZYGOFIX LTD2024-09-05

Other 510(k) Records For Product Code MRW

510(k)DeviceApplicantDecision date
K253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc.2026-05-14
K253432DiversiVy™ Facet Screw SystemVy Spine, LLC2026-03-19
K251714Ion-CSurGenTec, LLC2026-01-16
K250679FFX Facet Fixation SystemSc Medica2025-12-04
K253190CORUS-LX ImplantProvidence Medical Technology, Inc.2025-11-20
K252153FFX Facet Fixation SystemSc Medica2025-10-16
K251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantProvidence Medical Technology, Inc.2025-07-10
K250920Arthrex Spine Compression FT ScrewArthrex, Inc.2025-05-22
K242527The Karma® Fixation SystemSpinal Elements, Inc.2025-05-21
K243865AERO MIS Facet Fusion SystemAurora Spine2025-03-24
K243265Ion 3DSurGenTec, LLC2024-12-04
K242650zLOCK Lumbar Facet Fixation SystemZygofix , Ltd.2024-09-20
K241035PMT Posterior Cervical Stabilization System (PCSS)Providence Medical Technology, Inc.2024-06-25
K241416Ion 3DSurGenTec, LLC2024-06-17
K232468SC Medica FFXSc Medica2024-05-09