Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STRYKER NAV3I PLATFORM

K-Number: K130874 · 2013-09-27

ApplicantStryker Corporate
Decision Date2013-09-27
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STRYKER NAV3I PLATFORM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporate. It received FDA 510(k) clearance on 2013-09-27 under 510(k) number K130874. 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 STRYKER NAV3I PLATFORM?

STRYKER NAV3I PLATFORM is a medical device that received FDA 510(k) clearance on 2013-09-27. The listed applicant is Stryker Corporate. The 510(k) number is K130874.

When did STRYKER NAV3I PLATFORM receive FDA 510(k) clearance?

STRYKER NAV3I PLATFORM received FDA 510(k) clearance on 2013-09-27, under 510(k) number K130874.

Who is the listed applicant for STRYKER NAV3I PLATFORM?

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 STRYKER NAV3I PLATFORM?

The FDA product code for STRYKER NAV3I PLATFORM 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SystemK131214CRANIAL MAP NEURO

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.

↑