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FDA 510(k)

TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK

K-Number: K090953 · 2010-01-21

ApplicantPraxim Medivision, SA
Decision Date2010-01-21
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK is the device name listed in this FDA 510(k) record. The listed applicant is Praxim Medivision, SA. It received FDA 510(k) clearance on 2010-01-21 under 510(k) number K090953. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK?

TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK is a medical device that received FDA 510(k) clearance on 2010-01-21. The listed applicant is Praxim Medivision, SA. The 510(k) number is K090953.

When did TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK receive FDA 510(k) clearance?

TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK received FDA 510(k) clearance on 2010-01-21, under 510(k) number K090953.

Who is the listed applicant for TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK?

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

What is the FDA product code for TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK?

The FDA product code for TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK is OLO.

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 Medivision, SA 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.

K063408CTLOGICS NAVIGATIONS SYSTEMS

Related Devices (Code: OLO)

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.

K262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp.K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K262121Ion-L Navigated InstrumentsSurGenTec, LLCK261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics

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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