Uni Knee Surgetics Navigation System

FDA 510(k) K062146 · Praxim S.A

Substantially Equivalent

510(k) numberK062146

Submission

Device name
Uni Knee Surgetics Navigation System
Applicant
Praxim S.A
La Tronche, FR
Received
July 27, 2006
Decision date
August 21, 2006
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HAW – Neurological Stereotaxic Instrument
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4560
Specialty
Neurology

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K253663Zeta Navigation SystemHAW · Traditional Zeta Surgical, Inc.05/01/2026SE
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K242575Stereotaxic Guiding Surgical Devices, NaoTrac SHAW · Traditional Brain Navi Biotechnology Co., Ltd.05/23/2025SE
K241327Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional Claronav02/05/2025SE

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Questions and answers

When was Uni Knee Surgetics Navigation System cleared by the FDA?

Uni Knee Surgetics Navigation System (K062146) received a 510(k) decision of Substantially Equivalent on August 21, 2006, 25 days after the submission was received.

What is the product code of K062146?

The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.