FDA.reportPublic FDA data

510(k) K223627

Device
PreView-III? Anterior Cervical Plate System
Applicant
Nexus Spine, LLC
510(k) number
K223627
Product code
KWQ
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-02
Date received
2022-12-05
Regulation
888.3060
Classification name
Appliance, Fixation, Spinal Intervertebral Body
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jared Crocker
Address
2825 E. Cottonwood Pkwy. Suite 330 Salt Lake City UT US 84121 84121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KWQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.2026-05-14
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K260570corra™ cervical plating systemCarlsmed, Inc.2026-04-22
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K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.2026-03-03
K254182AsterOsteonic Co., Ltd.2026-02-26
K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.2026-02-12
K252611aprevo® cervical plating systemCarlsmed, Inc.2025-12-22
K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.2025-08-28
K251436Resolve Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.2025-07-11
K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.2025-05-23
K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.2025-05-20
K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)2025-04-10
K243904Elegance® Anterior Cervical plateClariance2025-01-14