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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 the device name listed in this FDA 510(k) record. The listed applicant is Kalitec Direct, LLC Doing Business AS Kalitec Medical. It received FDA 510(k) clearance on 2023-12-13 under 510(k) 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. The listed applicant is Kalitec Direct, LLC Doing Business AS Kalitec Medical. The 510(k) number is K232572.

When did Kalitec Navigated Instrument System receive FDA 510(k) clearance?

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

Who is the listed applicant for Kalitec Navigated Instrument System?

The FDA 510(k) record lists Kalitec Direct, LLC Doing Business AS Kalitec Medical as the applicant. This does not by itself establish the device manufacturer.

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

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

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.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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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