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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 a medical device manufactured by Arftx Medical, LLC. It received FDA 510(k) clearance on 2022-10-06 under approval 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. It is manufactured by Arftx Medical, LLC. The 510(k) number is K211892.

When was ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) approved by the FDA?

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

What company makes ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)?

ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) is manufactured by Arftx Medical, LLC.

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)

K172330Blustone Synergy Silica SystemBlustone Synergy K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc. K172323Omnia Medical VBROmnia Medical, LLC K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine K171704CAPRI Corpectomy Cage SystemK2m

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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