# Sintea Plustek, LLC

- Location (FDA's records): Fr. Myers, FL
- FDA decisions: 4 (2012–2014): 4 510(k) clearances
- Names in FDA's records: Sintea Plustek, LLC (3); Sintea Plustek (1)
- Product codes: NDN (1), MNH (1), KWQ (1), MAX (1)
- Predicates its devices cite: 10 (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
- Sintea Biotech, Inc.: 2 (https://510kreport.com/company/sintea-biotech)
- Cardinal Health, Inc.: 1 (https://510kreport.com/company/cardinal-health)
- Disc-O-Tech Medical Technologies, Ltd.: 1 (https://510kreport.com/company/disc-o-tech-medical-technologies)
- Synthes Spine: 1 (https://510kreport.com/company/synthes-spine)
- A Johnson & Johnson Company: 1 (https://510kreport.com/company/a-johnson-johnson)
- Stryker Spine: 1 (https://510kreport.com/company/stryker-spine)
- Depuy Spine, Inc.: 1 (https://510kreport.com/company/depuy-spine)
- Spine Next America: 1 (https://510kreport.com/company/spine-next-america)

## Recent decisions
- K132907: Plif Lite and Tlif Lite (Jul 24, 2014)
- K140787: PLS (Posterior Lumbar System) (May 30, 2014)
- K130402: Spider System Kolibri Cement Needle (Apr 1, 2013)
- K112861: Sintea Plustek Anterior Cervical Plate System (Feb 24, 2012)

Source page: https://510kreport.com/company/sintea-plustek