# Kalitec Direct, LLC Doing Business AS Kalitec Medical

- Location (FDA's records): Orlando, FL
- FDA decisions: 1 (2023–2023): 1 510(k) clearance
- Product codes: OLO (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kalitec Direct, LLC: 2 (https://510kreport.com/company/kalitec-direct)
- Medtronic Navigation, Inc.: 1 (https://510kreport.com/company/medtronic-navigation)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)

## Recent decisions
- K232572: Kalitec Navigated Instrument System (Dec 13, 2023)

Source page: https://510kreport.com/company/kalitec-direct-doing-business-as-kalitec-medical