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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 the device name listed in this FDA 510(k) record. The listed applicant is Artfx Medical. It received FDA 510(k) clearance on 2024-06-28 under 510(k) 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. The listed applicant is Artfx Medical. The 510(k) number is K240893.

When did ARTFX MEDICAL Cervical PEEK Cages receive FDA 510(k) clearance?

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

Who is the listed applicant for ARTFX MEDICAL Cervical PEEK Cages?

The FDA 510(k) record lists Artfx Medical as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Artfx Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242939ARTFX Trauma Bone Plate and Screw SystemK240889ARTFX Lumbar PEEK CagesK212220ArtFX Spinal Fixation SystemK211718Venus Cervical Plate System

Related Devices (Code: ODP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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