Kalitec Navigated Instrument System— 510(k) K232572

Name: FDA 510(k) clearance K232572
Creator: U.S. Food and Drug Administration
Published: 2023-12-13

Substantially Equivalent

Kalitec Direct, LLC Doing Business AS Kalitec Medical

FDA 510(k) clearance K232572 for Kalitec Navigated Instrument System, Substantially Equivalent on 2023-12-13. Applicant: Kalitec Direct, LLC Doing Business AS Kalitec Medical. Device class: 2.

Clearance details

Applicant: Kalitec Direct, LLC Doing Business AS Kalitec Medical
Product code: Code OLO
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2023-08-24
Decision date: 2023-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLO

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K262506 — Remex Spine Surgery Navigation - Universal Instruments2026-08-20
K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))2026-07-30
K261205 — SPINEART Navigation Instrument System2026-07-29
K261024 — TMINI Miniature Robotic System2026-07-24
K262121 — Ion-L Navigated Instruments2026-07-24

Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.