FDA.report

510(k) K231145

Device
Axis Anterior Cervical Plate System
Applicant
Southern Medical (Pty) , Ltd.
510(k) number
K231145
Product code
KWQ
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-13
Date received
2023-04-21
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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Dalene Styger
Address
55 Regency Dr. Rte. 21 Corporate Park Irene ZA 0178 0178

FDA Registration Numbers

Source Documents

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

Other 510(k) Records For Product Code KWQ

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K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.2026-02-12
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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