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FDA 510(k)

IVA & AEON Cervical and Lumbar Cage System

K-Number: K250335 · 2025-08-29

ApplicantK&J Consulting
Decision Date2025-08-29
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IVA & AEON Cervical and Lumbar Cage System is a medical device manufactured by K&J Consulting. It received FDA 510(k) clearance on 2025-08-29 under approval number K250335. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IVA & AEON Cervical and Lumbar Cage System?

IVA & AEON Cervical and Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2025-08-29. It is manufactured by K&J Consulting. The 510(k) number is K250335.

When was IVA & AEON Cervical and Lumbar Cage System approved by the FDA?

IVA & AEON Cervical and Lumbar Cage System received FDA 510(k) clearance on 2025-08-29, under approval number K250335.

What company makes IVA & AEON Cervical and Lumbar Cage System?

IVA & AEON Cervical and Lumbar Cage System is manufactured by K&J Consulting.

What is the FDA product code for IVA & AEON Cervical and Lumbar Cage System?

The FDA product code for IVA & AEON Cervical and Lumbar Cage System is ODP.

Related Clinical Trials

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 NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT07277803 Device-Based vs Manual Sensory Training in Low Back Pain NOT_YET_RECRUITING NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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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