HipXpert and HipInsight System— 510(k) K233315

Name: FDA 510(k) clearance K233315
Creator: U.S. Food and Drug Administration
Published: 2024-08-08

Substantially Equivalent

Surgical Planning Associates, Inc.

FDA 510(k) clearance K233315 for HipXpert and HipInsight System, Substantially Equivalent on 2024-08-08. 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: 2023-09-29
Decision date: 2024-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OSF

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K200384 — HipXpert 3D Display and Anchoring Application2021-01-28
K093491 — HIP SEXTANT INSTRUMENT SYSTEM2010-12-09

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