Cleared Traditional

K222515 - FaSet Fixation System (FDA 510(k) Clearance)

K222515 · Dio Medical Corporation · Orthopedic device

Oct 2022

Decision

47d

Days

Risk

K222515 is an FDA 510(k) clearance for the FaSet Fixation System. This device is classified as a System, Facet Screw Spinal Device.

Submitted by Dio Medical Corporation (East Norriton, US). The FDA issued a Cleared decision on October 5, 2022, 47 days after receiving the submission on August 19, 2022.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K222515 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 19, 2022
Decision Date	October 05, 2022
Days to Decision	47 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF