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FDA 510(k)

SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM

K-Number: K031196 · 2005-06-07

ApplicantPraxim
Decision Date2005-06-07
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Praxim. It received FDA 510(k) clearance on 2005-06-07 under 510(k) number K031196. 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 SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM?

SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 2005-06-07. The listed applicant is Praxim. The 510(k) number is K031196.

When did SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM receive FDA 510(k) clearance?

SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM received FDA 510(k) clearance on 2005-06-07, under 510(k) number K031196.

Who is the listed applicant for SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM?

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

What is the FDA product code for SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM?

The FDA product code for SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM 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 Praxim 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.

K081232TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELESK022239SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM

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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