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FDA 510(k)

SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION

K-Number: K994421 · 2000-02-23

ApplicantSurgical Navigation Specialists, Inc.
Decision Date2000-02-23
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Navigation Specialists, Inc.. It received FDA 510(k) clearance on 2000-02-23 under 510(k) number K994421. 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 SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION?

SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION is a medical device that received FDA 510(k) clearance on 2000-02-23. The listed applicant is Surgical Navigation Specialists, Inc.. The 510(k) number is K994421.

When did SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION receive FDA 510(k) clearance?

SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION received FDA 510(k) clearance on 2000-02-23, under 510(k) number K994421.

Who is the listed applicant for SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION?

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

What is the FDA product code for SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION?

The FDA product code for SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION is HAW.

Related Clinical Trials

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.

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Other records listing Surgical Navigation Specialists, 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.

K010542SNN SYSTEM INCLUDING THE TOMOGUIDE OPTIONK992457SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION

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

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

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