FDA 510(k)

HipXpert and HipInsight System

K-Number: K233315 · 2024-08-08

ApplicantSurgical Planning Associates, Inc.

Decision Date2024-08-08

Product CodeOSF

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

HipXpert and HipInsight System is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Planning Associates, Inc.. It received FDA 510(k) clearance on 2024-08-08 under 510(k) number K233315. The device is classified under product code OSF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HipXpert and HipInsight System?

HipXpert and HipInsight System is a medical device that received FDA 510(k) clearance on 2024-08-08. The listed applicant is Surgical Planning Associates, Inc.. The 510(k) number is K233315.

When did HipXpert and HipInsight System receive FDA 510(k) clearance?

HipXpert and HipInsight System received FDA 510(k) clearance on 2024-08-08, under 510(k) number K233315.

Who is the listed applicant for HipXpert and HipInsight System?

The FDA 510(k) record lists Surgical Planning Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HipXpert and HipInsight System?

The FDA product code for HipXpert and HipInsight System is OSF.

Other records listing Surgical Planning Associates, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200384HipXpert 3D Display and Anchoring Application

Related Devices (Code: OSF)

K200384HipXpert 3D Display and Anchoring ApplicationSurgical Planning Associates, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.