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FDA 510(k)

Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System

K-Number: K223719 · 2023-01-11

ApplicantAegis Spine, Inc.
Decision Date2023-01-11
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System is a medical device manufactured by Aegis Spine, Inc.. It received FDA 510(k) clearance on 2023-01-11 under approval number K223719. 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 Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System?

Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System is a medical device that received FDA 510(k) clearance on 2023-01-11. It is manufactured by Aegis Spine, Inc.. The 510(k) number is K223719.

When was Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System approved by the FDA?

Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System received FDA 510(k) clearance on 2023-01-11, under approval number K223719.

What company makes Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System?

Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System is manufactured by Aegis Spine, Inc..

What is the FDA product code for Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System?

The FDA product code for Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System is KWQ.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07610850 Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation NOT_YET_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED

Other Devices by Aegis Spine, Inc.

K203531XYPAN Expandable Lumbar Cage System K221719ABTross ALIF Expandable Cage System K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System K223521ZESPIN SI Joint Fusion 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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