Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Kalitec Navigated Instrument System

K-Number: K232572 · 2023-12-13

ApplicantKalitec Direct, LLC Doing Business AS Kalitec Medical
Decision Date2023-12-13
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Kalitec Navigated Instrument System is a medical device manufactured by Kalitec Direct, LLC Doing Business AS Kalitec Medical. It received FDA 510(k) clearance on 2023-12-13 under approval number K232572. 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 Kalitec Navigated Instrument System?

Kalitec Navigated Instrument System is a medical device that received FDA 510(k) clearance on 2023-12-13. It is manufactured by Kalitec Direct, LLC Doing Business AS Kalitec Medical. The 510(k) number is K232572.

When was Kalitec Navigated Instrument System approved by the FDA?

Kalitec Navigated Instrument System received FDA 510(k) clearance on 2023-12-13, under approval number K232572.

What company makes Kalitec Navigated Instrument System?

Kalitec Navigated Instrument System is manufactured by Kalitec Direct, LLC Doing Business AS Kalitec Medical.

What is the FDA product code for Kalitec Navigated Instrument System?

The FDA product code for Kalitec Navigated Instrument System is OLO.

Related Clinical Trials

NCT05150197 Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease RECRUITING NCT07516145 Robotic Transjugular Transcatheter Tricuspid Valve Replacement RECRUITING NCT07139808 Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System RECRUITING NCT07092436 Pediatric Upper-Limb Rehabilitation With PhiCube, a Modular Bilateral End-Effector Device RECRUITING

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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.

↑