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FDA 510(k)

Axis Anterior Cervical Plate System

K-Number: K231145 · 2023-06-13

ApplicantSouthern Medical (Pty) , Ltd.
Decision Date2023-06-13
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Axis Anterior Cervical Plate System is a medical device manufactured by Southern Medical (Pty) , Ltd.. It received FDA 510(k) clearance on 2023-06-13 under approval number K231145. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Axis Anterior Cervical Plate System?

Axis Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2023-06-13. It is manufactured by Southern Medical (Pty) , Ltd.. The 510(k) number is K231145.

When was Axis Anterior Cervical Plate System approved by the FDA?

Axis Anterior Cervical Plate System received FDA 510(k) clearance on 2023-06-13, under approval number K231145.

What company makes Axis Anterior Cervical Plate System?

Axis Anterior Cervical Plate System is manufactured by Southern Medical (Pty) , Ltd..

What is the FDA product code for Axis Anterior Cervical Plate System?

The FDA product code for Axis Anterior Cervical Plate System is KWQ.

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Other Devices by Southern Medical (Pty) , Ltd.

K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF) K221447Southern Anterior Screw Fixated Cage (SASCA) K230607SPICCA Cervical Fusion Cages K230608SPICCA Stand-Alone Cervical Fusion Cages K253373Southern Craniomaxillofacial (CMF) System

Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, 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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