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FDA 510(k)

CRANIAL MAP NEURO

K-Number: K131214 · 2013-10-18

ApplicantStryker Corporate
Decision Date2013-10-18
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CRANIAL MAP NEURO is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporate. It received FDA 510(k) clearance on 2013-10-18 under 510(k) number K131214. 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 CRANIAL MAP NEURO?

CRANIAL MAP NEURO is a medical device that received FDA 510(k) clearance on 2013-10-18. The listed applicant is Stryker Corporate. The 510(k) number is K131214.

When did CRANIAL MAP NEURO receive FDA 510(k) clearance?

CRANIAL MAP NEURO received FDA 510(k) clearance on 2013-10-18, under 510(k) number K131214.

Who is the listed applicant for CRANIAL MAP NEURO?

The FDA 510(k) record lists Stryker Corporate as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRANIAL MAP NEURO?

The FDA product code for CRANIAL MAP NEURO is HAW.

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Other records listing Stryker Corporate 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.

K153240Styrker OrthoMap Express Knee SystemK130874STRYKER NAV3I PLATFORM

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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