CenterMed Patient Matched Assisted Surgical Planning (ASP) System— 510(k) K201353

Name: FDA 510(k) clearance K201353
Creator: U.S. Food and Drug Administration
Published: 2021-06-28

Substantially Equivalent

Centermed, Inc.

FDA 510(k) clearance K201353 for CenterMed Patient Matched Assisted Surgical Planning (ASP) System, Substantially Equivalent on 2021-06-28. Applicant: Centermed, Inc.. Device class: 2.

Clearance details

Applicant: Centermed, Inc.
Product code: Code DZJ
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2020-05-21
Decision date: 2021-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walnut Creek, CA, US

Download summary PDF View on FDA.gov ↗

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