Cleared Traditional

?POINT? Kinguide Agile Hybrid Navigation System

K230087 · Point Robotics MedTech, Inc. · Orthopedic

Jul 2023

Decision

186d

Days

Class 2

Risk

About This 510(k) Submission

K230087 is an FDA 510(k) clearance for the ?POINT? Kinguide Agile Hybrid Navigation System, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Point Robotics MedTech, Inc. (New Taipei City, TW). The FDA issued a Cleared decision on July 17, 2023, 186 days after receiving the submission on January 12, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K230087 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 12, 2023
Decision Date	July 17, 2023
Days to Decision	186 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OLO — Orthopedic Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.