HipXpert 3D Display and Anchoring Application— 510(k) K200384

Name: FDA 510(k) clearance K200384
Creator: U.S. Food and Drug Administration
Published: 2021-01-28

Substantially Equivalent

Surgical Planning Associates, Inc.

FDA 510(k) clearance K200384 for HipXpert 3D Display and Anchoring Application, Substantially Equivalent on 2021-01-28. Applicant: Surgical Planning Associates, Inc.. Device class: 2.

Clearance details

Applicant: Surgical Planning Associates, Inc.
Product code: Code OSF
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2020-02-18
Decision date: 2021-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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