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FDA 510(k)

ARTFX MEDICAL Cervical PEEK Cages

K-Number: K240893 · 2024-06-28

ApplicantArtfx Medical
Decision Date2024-06-28
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTFX MEDICAL Cervical PEEK Cages is a medical device manufactured by Artfx Medical. It received FDA 510(k) clearance on 2024-06-28 under approval number K240893. 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 ARTFX MEDICAL Cervical PEEK Cages?

ARTFX MEDICAL Cervical PEEK Cages is a medical device that received FDA 510(k) clearance on 2024-06-28. It is manufactured by Artfx Medical. The 510(k) number is K240893.

When was ARTFX MEDICAL Cervical PEEK Cages approved by the FDA?

ARTFX MEDICAL Cervical PEEK Cages received FDA 510(k) clearance on 2024-06-28, under approval number K240893.

What company makes ARTFX MEDICAL Cervical PEEK Cages?

ARTFX MEDICAL Cervical PEEK Cages is manufactured by Artfx Medical.

What is the FDA product code for ARTFX MEDICAL Cervical PEEK Cages?

The FDA product code for ARTFX MEDICAL Cervical PEEK Cages is ODP.

Related Clinical Trials

NCT05664854 Electrical Impedance Tomography & Selective Stimulation of Vagus Nerve RECRUITING NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT07577739 Noninvasive CA Monitoring Validation and Autonomic Modulation in Aneurysmal Subarachnoid Hemorrhage NOT_YET_RECRUITING

Other Devices by Artfx Medical

K242939ARTFX Trauma Bone Plate and Screw System K240889ARTFX Lumbar PEEK Cages

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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