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FDA 510(k)

STEALTHSTATION SYSTEM UPDATE

K-Number: K050438 · 2005-06-02

ApplicantMedtronic Surgical Navigation Technologies
Decision Date2005-06-02
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STEALTHSTATION SYSTEM UPDATE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Surgical Navigation Technologies. It received FDA 510(k) clearance on 2005-06-02 under 510(k) number K050438. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEALTHSTATION SYSTEM UPDATE?

STEALTHSTATION SYSTEM UPDATE is a medical device that received FDA 510(k) clearance on 2005-06-02. The listed applicant is Medtronic Surgical Navigation Technologies. The 510(k) number is K050438.

When did STEALTHSTATION SYSTEM UPDATE receive FDA 510(k) clearance?

STEALTHSTATION SYSTEM UPDATE received FDA 510(k) clearance on 2005-06-02, under 510(k) number K050438.

Who is the listed applicant for STEALTHSTATION SYSTEM UPDATE?

The FDA 510(k) record lists Medtronic Surgical Navigation Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STEALTHSTATION SYSTEM UPDATE?

The FDA product code for STEALTHSTATION SYSTEM UPDATE is HAW.

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Other records listing Medtronic Surgical Navigation Technologies 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.

K043088MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULEK030552IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEMK030106STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULEK022126CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEMK021980HIP MODULE FOR THE STEALTHSTATION SYSTEMK022414STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE

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Related Devices (Code: HAW)

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.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

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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