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FDA 510(k)

MARKER SYSTEM FOR STEREOTAXIC NAVIGATION

K-Number: K961120 · 1996-05-10

ApplicantHowmedica Leibinger, Inc.
Decision Date1996-05-10
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MARKER SYSTEM FOR STEREOTAXIC NAVIGATION is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Leibinger, Inc.. It received FDA 510(k) clearance on 1996-05-10 under 510(k) number K961120. 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 MARKER SYSTEM FOR STEREOTAXIC NAVIGATION?

MARKER SYSTEM FOR STEREOTAXIC NAVIGATION is a medical device that received FDA 510(k) clearance on 1996-05-10. The listed applicant is Howmedica Leibinger, Inc.. The 510(k) number is K961120.

When did MARKER SYSTEM FOR STEREOTAXIC NAVIGATION receive FDA 510(k) clearance?

MARKER SYSTEM FOR STEREOTAXIC NAVIGATION received FDA 510(k) clearance on 1996-05-10, under 510(k) number K961120.

Who is the listed applicant for MARKER SYSTEM FOR STEREOTAXIC NAVIGATION?

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

What is the FDA product code for MARKER SYSTEM FOR STEREOTAXIC NAVIGATION?

The FDA product code for MARKER SYSTEM FOR STEREOTAXIC NAVIGATION is HAW.

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Other records listing Howmedica Leibinger, 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.

K970912LEIBINGER SELF-DRILLING SCREWK972154COHEN DISTRACTORK972166GUERRERO - BELL DISTRACTORK961719EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESESK970911LEE PLATEK963030LEIBINGER IMF SCREW

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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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