Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

X-Guide Surgical Navigation System

K-Number: K232148 · 2024-02-21

Decision Date2024-02-21
Product CodeQRY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

X-Guide Surgical Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is X-Nav Technologies, LLC. It received FDA 510(k) clearance on 2024-02-21 under 510(k) number K232148. The device is classified under product code QRY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-Guide Surgical Navigation System?

X-Guide Surgical Navigation System is a medical device that received FDA 510(k) clearance on 2024-02-21. The listed applicant is X-Nav Technologies, LLC. The 510(k) number is K232148.

When did X-Guide Surgical Navigation System receive FDA 510(k) clearance?

X-Guide Surgical Navigation System received FDA 510(k) clearance on 2024-02-21, under 510(k) number K232148.

Who is the listed applicant for X-Guide Surgical Navigation System?

The FDA 510(k) record lists X-Nav Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-Guide Surgical Navigation System?

The FDA product code for X-Guide Surgical Navigation System is QRY.

Other records listing X-Nav Technologies, LLC 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.

Related Devices (Code: QRY)

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.

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.