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FDA 510(k)

X-Guide® Surgical Navigation System

K-Number: K211701 · 2022-02-01

ApplicantX-Nav Technologies, LLC
Decision Date2022-02-01
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 2022-02-01 under 510(k) number K211701. 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 2022-02-01. The listed applicant is X-Nav Technologies, LLC. The 510(k) number is K211701.

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

X-Guide® Surgical Navigation System received FDA 510(k) clearance on 2022-02-01, under 510(k) number K211701.

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.

K232148X-Guide Surgical Navigation SystemK200662X-Guide® Surgical Navigation SystemK192579X-Guide Surgical Navigation System

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.

K232148X-Guide Surgical Navigation SystemX-Nav Technologies, LLCK222750Yomi Robotic SystemNeocis, Inc.K222049Yomi Robotic SystemNeocis, 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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