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FDA 510(k)

ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)

K-Number: K211892 · 2022-10-06

ApplicantArftx Medical, LLC
Decision Date2022-10-06
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) is the device name listed in this FDA 510(k) record. The listed applicant is Arftx Medical, LLC. It received FDA 510(k) clearance on 2022-10-06 under 510(k) number K211892. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)?

ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) is a medical device that received FDA 510(k) clearance on 2022-10-06. The listed applicant is Arftx Medical, LLC. The 510(k) number is K211892.

When did ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) receive FDA 510(k) clearance?

ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) received FDA 510(k) clearance on 2022-10-06, under 510(k) number K211892.

Who is the listed applicant for ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)?

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

What is the FDA product code for ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)?

The FDA product code for ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) is MQP.

Related Devices (Code: MQP)

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.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura Medical

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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