Deformity Analysis and Correction Software (DACS) and Instrumentation— 510(k) K180539

Name: FDA 510(k) clearance K180539
Creator: U.S. Food and Drug Administration
Published: 2018-08-13

Substantially Equivalent

Arrowhead Medical Device Technologies, LLC

FDA 510(k) clearance K180539 for Deformity Analysis and Correction Software (DACS) and Instrumentation, Substantially Equivalent on 2018-08-13. Applicant: Arrowhead Medical Device Technologies, LLC. Device class: 2.

Clearance details

Applicant: Arrowhead Medical Device Technologies, LLC
Product code: Code OSN
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2018-02-28
Decision date: 2018-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Collierville, TN, US

Download summary PDF View on FDA.gov ↗

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