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FDA 510(k)

SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM

K-Number: K053542 · 2006-04-10

ApplicantPraxim S.A
Decision Date2006-04-10
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Praxim S.A. It received FDA 510(k) clearance on 2006-04-10 under 510(k) number K053542. 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 OSTEOLOGICS NAVIGATION SYSTEM?

SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 2006-04-10. The listed applicant is Praxim S.A. The 510(k) number is K053542.

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

SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM received FDA 510(k) clearance on 2006-04-10, under 510(k) number K053542.

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

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

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

The FDA product code for SURGETICS ORTHO OSTEOLOGICS 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 S.A 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.

K072267TOTAL HIP SURGETICS NAVIGATION SYSTEMK062146UNI KNEE SURGETICS NAVIGATION SYSTEMK060282TOTAL KNEE SURGETICS 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

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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