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FDA 510(k)

HipXpert 3D Display and Anchoring Application

K-Number: K200384 · 2021-01-28

ApplicantSurgical Planning Associates, Inc.
Decision Date2021-01-28
Product CodeOSF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HipXpert 3D Display and Anchoring Application 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 2021-01-28 under 510(k) number K200384. 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 3D Display and Anchoring Application?

HipXpert 3D Display and Anchoring Application is a medical device that received FDA 510(k) clearance on 2021-01-28. The listed applicant is Surgical Planning Associates, Inc.. The 510(k) number is K200384.

When did HipXpert 3D Display and Anchoring Application receive FDA 510(k) clearance?

HipXpert 3D Display and Anchoring Application received FDA 510(k) clearance on 2021-01-28, under 510(k) number K200384.

Who is the listed applicant for HipXpert 3D Display and Anchoring Application?

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 3D Display and Anchoring Application?

The FDA product code for HipXpert 3D Display and Anchoring Application 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.

K233315HipXpert and HipInsight System

Related Devices (Code: OSF)

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.

K233315HipXpert and HipInsight SystemSurgical Planning Associates, Inc.

Official Source

View on FDA Database →

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

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