Cleared Traditional

ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)

K211892 · Arftx Medical, LLC · Orthopedic

Oct 2022

Decision

472d

Days

Class 2

Risk

About This 510(k) Submission

K211892 is an FDA 510(k) clearance for the ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages), a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by Arftx Medical, LLC (Jacksonville, US). The FDA issued a Cleared decision on October 6, 2022, 472 days after receiving the submission on June 21, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K211892 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 2021
Decision Date	October 06, 2022
Days to Decision	472 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF