# Kalitec Medical, LLC

- Location (FDA's records): Orlando, FL
- FDA decisions: 3 (2019–2023): 3 510(k) clearances
- Names in FDA's records: Kalitec Medical, LLC (2); Kalitec Medical (1)
- Product codes: MAX (2), NKB (1)
- 510(k) review time since 2016: median 145 days, against 95 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 13 (0 its own); citations of its devices by later devices: 1 (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: 5 (https://510kreport.com/company/kalitec-direct)
- K2m, Inc.: 4 (https://510kreport.com/company/k2m)
- Spinal Elements, Inc.: 1 (https://510kreport.com/company/spinal-elements)
- Ht Medical, LLC: 1 (https://510kreport.com/company/ht-medical)
- Zimmer Spine, Inc.: 1 (https://510kreport.com/company/zimmer-spine)
- Depuy Spine, Inc.: 1 (https://510kreport.com/company/depuy-spine)

## Firms that cite its devices most
- Ht Medical D.B.A. Xenix Medical: 1 (https://510kreport.com/company/ht-medical-dba-xenix-medical)

## Its most-cited devices
- K182210: TiWAVE-L Porous Titanium Lumbar Cage (2019), cited by 1

## Recent decisions
- K230974: NIDO™ Pedicle Screw System (Sep 15, 2023)
- K220902: Navagio Lumbar Cage (May 27, 2022)
- K182210: TiWAVE-L Porous Titanium Lumbar Cage (Jan 7, 2019)

Source page: https://510kreport.com/company/kalitec-medical