FaSet Fixation System— 510(k) K222515

Name: FDA 510(k) clearance K222515
Creator: U.S. Food and Drug Administration
Published: 2022-10-05

Substantially Equivalent

Dio Medical Corporation

FDA 510(k) clearance K222515 for FaSet Fixation System, Substantially Equivalent on 2022-10-05. Applicant: Dio Medical Corporation. Device class: Unclassified.

Clearance details

Applicant: Dio Medical Corporation
Product code: Code MRW
Device class: Unclassified
Advisory panel: Unknown
Date received: 2022-08-19
Decision date: 2022-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Norriton, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.